Cleared Special

Sure-Fine Insulin Syringes

K191531 · Shina Med Corporation · General Hospital
Sep 2019
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K191531 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 6, 2019, 88 days after receiving the submission on June 10, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K191531 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2019
Decision Date September 06, 2019
Days to Decision 88 days
Submission Type Special
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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