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510(k) Number K161689 For OSSTEM Implant System - Abutment From OSSTEM IMPLANT Co., Ltd.

Date Received: 2016-06-20

Decision Date: 2017-05-22

Contact: Hee Kwon

Address:

City: Busan

State:

Product Code: NHA

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Dental

Advisory Committee Code under which the product was classified: DE

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K161370 For Durepair Dura Regeneration Matrix From Medtronic Neurosurgery

Date Received: 2016-05-17

Decision Date: 2016-11-02

Contact: Manas Lele

Address:

City: Goleta

State: CA

Product Code: GXQ

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Neurology

Advisory Committee Code under which the product was classified: NE

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K161327 For SYNTEC HUMERAL NAIL SYSTEM From SYNTEC SCIENTIFIC CORPORATION

Date Received: 2016-05-12

Decision Date: 2017-06-08

Contact: KAVIN CHU

Address:

City: CHANG HUA

State:

Product Code: HSB

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Orthopedic

Advisory Committee Code under which the product was classified: OR

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K161277 For ConvertX Nephroureteral Stent System From BRIGHTWATER MEDICAL

Date Received: 2016-05-06

Decision Date: 2016-11-22

Contact: BOB SMOUSE

Address:

City: DUNLAP

State: IL

Product Code: FAD

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Gastroenterology, Urology

Advisory Committee Code under which the product was classified: GU

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K161246 For Ez3D-i / E3 From EWOO SOFT CO., LTD.

Date Received: 2016-05-03

Decision Date: 2016-05-31

Contact: Young Seok Kim

Address:

City: HWASEONG-SI

State:

Product Code: LLZ

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Radiology

Advisory Committee Code under which the product was classified: RA

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K161216 For Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators From IMMUNALYSIS CORPORATION

Date Received: 2016-04-29

Decision Date: 2017-06-14

Contact: Joseph Ginete

Address:

City: POMONA

State: CA

Product Code: DJG

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Clinical Toxicology

Advisory Committee Code under which the product was classified: TX

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K161127 For The Small PLATEAU (PLATEAU-C) Spacer System From LIFE SPINE INC.

Date Received: 2016-04-21

Decision Date: 2016-12-22

Contact: RANDY LEWIS

Address:

City: Huntley

State: IL

Product Code: ODP

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Orthopedic

Advisory Committee Code under which the product was classified: OR

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K160941 For Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter From Brosmed Medical Co., Ltd.

Date Received: 2016-04-04

Decision Date: 2016-12-13

Contact: Tina Yin

Address:

City: Dongguan

State:

Product Code: LIT

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Cardiovascular

Advisory Committee Code under which the product was classified: CV

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K160847 For Rockwell Medical CitraPure Acid Concetrate From ROCKWELL MEDICAL

Date Received: 2016-03-28

Decision Date: 2016-10-20

Contact: ROBERT CHIOINI

Address:

City: WIXOM

State: MI

Product Code: KPO

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Summary

Advisory Committee: Gastroenterology, Urology

Advisory Committee Code under which the product was classified: GU

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K012291 For HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA From THE BINDING SITE, LTD.

Date Received: 2001-07-20

Decision Date: 2001-08-20

Contact: JAY GELLER

Address:

City: SANTA MONICA

State: CA

Product Code: CFN

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary: Statement

Advisory Committee: Immunology

Advisory Committee Code under which the product was classified: IM

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number/Type	Applicant	Device	Advisory Committe	Date Received	Decision Date	More Info
K161689	OSSTEM IMPLANT Co., Ltd.	OSSTEM Implant System - Abutment	Dental	2016-06-20	2017-05-22
K161370	Medtronic Neurosurgery	Durepair Dura Regeneration Matrix	Neurology	2016-05-17	2016-11-02
K161327	SYNTEC SCIENTIFIC CORPORATION	SYNTEC HUMERAL NAIL SYSTEM	Orthopedic	2016-05-12	2017-06-08
K161277	BRIGHTWATER MEDICAL	ConvertX Nephroureteral Stent System	Gastroenterology, Urology	2016-05-06	2016-11-22
K161246	EWOO SOFT CO., LTD.	Ez3D-i / E3	Radiology	2016-05-03	2016-05-31
K161216	IMMUNALYSIS CORPORATION	Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators	Clinical Toxicology	2016-04-29	2017-06-14
K161127	LIFE SPINE INC.	The Small PLATEAU (PLATEAU-C) Spacer System	Orthopedic	2016-04-21	2016-12-22
K160941	Brosmed Medical Co., Ltd.	Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter	Cardiovascular	2016-04-04	2016-12-13
K160847	ROCKWELL MEDICAL	Rockwell Medical CitraPure Acid Concetrate	Gastroenterology, Urology	2016-03-28	2016-10-20
K012291	THE BINDING SITE, LTD.	HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA	Immunology	2001-07-20	2001-08-20

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