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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K173743
Device Name Greenmedi Safety Filter Syringe
Applicant
Sang-A Frontec Co., Ltd.
18, Namdong-Daero 369beon-Gil, Namdong-Gu
Incheon,  KR 21629
Applicant Contact Park Sung-soon
Correspondent
LK Consulting Group USA, Inc.
690 Roosevelt
690 Roosevelt,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number880.5860
Classification Product Code
MEG  
Date Received12/07/2017
Decision Date 01/28/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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