Cleared Traditional

TK Insulin Syringe with/without Saftey Retractable Device

K191639 · Anhui Tiankang Medical Technology Co., Ltd. · General Hospital
Sep 2020
Decision
450d
Days
Class 2
Risk

About This 510(k) Submission

K191639 is an FDA 510(k) clearance for the TK Insulin Syringe with/without Saftey Retractable Device, a Syringe, Antistick (Class II — Special Controls, product code MEG), submitted by Anhui Tiankang Medical Technology Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on September 11, 2020, 450 days after receiving the submission on June 19, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K191639 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2019
Decision Date September 11, 2020
Days to Decision 450 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MEG — Syringe, Antistick
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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