Premium Plus Disposable Barrier Sleeve— 510(k) K163447

Name: FDA 510(k) clearance K163447
Creator: U.S. Food and Drug Administration
Published: 2017-06-20

Substantially Equivalent

Premium Plus International Limited

FDA 510(k) clearance K163447 for Premium Plus Disposable Barrier Sleeve, Substantially Equivalent on 2017-06-20. Applicant: Premium Plus International Limited. Device class: 2.

Clearance details

Applicant: Premium Plus International Limited
Product code: Code PEM
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2016-12-08
Decision date: 2017-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, 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.