Disposable Barrier Sleeves— 510(k) K220662

Name: FDA 510(k) clearance K220662
Creator: U.S. Food and Drug Administration
Published: 2022-05-11

Substantially Equivalent

Premium Plus (Dongguan) Limited

FDA 510(k) clearance K220662 for Disposable Barrier Sleeves, Substantially Equivalent on 2022-05-11. Applicant: Premium Plus (Dongguan) Limited. Device class: 2.

Clearance details

Applicant: Premium Plus (Dongguan) Limited
Product code: Code PEM
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2022-03-07
Decision date: 2022-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.