Cleared Traditional

Sure-Fine Insulin Syringes

K152879 · Shina Med Corporation · General Hospital
Sep 2016
Decision
345d
Days
Class 2
Risk

About This 510(k) Submission

K152879 is an FDA 510(k) clearance for the Sure-Fine Insulin Syringes, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Shina Med Corporation (Anseong-Si, KR). The FDA issued a Cleared decision on September 9, 2016, 345 days after receiving the submission on September 30, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K152879 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2015
Decision Date September 09, 2016
Days to Decision 345 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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