The following data is part of a premarket notification filed by Sang-a Frontec Co., Ltd with the FDA for Greenmedi Safety Filter Syringe.
Device ID | K173743 |
510k Number | K173743 |
Device Name: | Greenmedi Safety Filter Syringe |
Classification | Syringe, Antistick |
Applicant | Sang-A Frontec Co., Ltd 18, Namdong-daero 369beon-gil, Namdong-gu Incheon, KR 21629 |
Contact | Park Sung-soon |
Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine, CA 92620 |
Product Code | MEG |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-07 |
Decision Date | 2019-01-28 |
Summary: | summary |