Greenmedi Safety Filter Syringe

Syringe, Antistick

Sang-A Frontec Co., Ltd

The following data is part of a premarket notification filed by Sang-a Frontec Co., Ltd with the FDA for Greenmedi Safety Filter Syringe.

Pre-market Notification Details

Device IDK173743
510k NumberK173743
Device Name:Greenmedi Safety Filter Syringe
ClassificationSyringe, Antistick
Applicant Sang-A Frontec Co., Ltd 18, Namdong-daero 369beon-gil, Namdong-gu Incheon,  KR 21629
ContactPark Sung-soon
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc. 690 Roosevelt Irvine,  CA  92620
Product CodeMEG  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-07
Decision Date2019-01-28
Summary:summary

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