BARRIER SAF-TE HYDROGEL DRAPE— 510(k) K922918

Name: FDA 510(k) clearance K922918
Creator: U.S. Food and Drug Administration
Published: 1993-07-06

Substantially Equivalent

Johnson & Johnson International

FDA 510(k) clearance K922918 for BARRIER SAF-TE HYDROGEL DRAPE, Substantially Equivalent on 1993-07-06. Applicant: Johnson & Johnson International. Device class: 2.

Clearance details

Applicant: Johnson & Johnson International
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1992-06-18
Decision date: 1993-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TX, US

Download summary PDF View on FDA.gov ↗

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