Cleared Traditional

Sharps container

K201523 · Zhejiang Gongdong Medical Technology Co., Ltd. · General Hospital
Nov 2020
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K201523 is an FDA 510(k) clearance for the Sharps container, a Container, Sharps (Class II — Special Controls, product code MMK), submitted by Zhejiang Gongdong Medical Technology Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on November 12, 2020, 157 days after receiving the submission on June 8, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K201523 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 2020
Decision Date November 12, 2020
Days to Decision 157 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MMK — Container, Sharps
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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