BARRIER ANTIMICROBIAL INCISE DRAPE— 510(k) K820543

Name: FDA 510(k) clearance K820543
Creator: U.S. Food and Drug Administration
Published: 1982-07-22

Substantially Equivalent

Surgikos, Inc.

FDA 510(k) clearance K820543 for BARRIER ANTIMICROBIAL INCISE DRAPE, Substantially Equivalent on 1982-07-22. Applicant: Surgikos, Inc.. Device class: 2.

Clearance details

Applicant: Surgikos, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1982-03-02
Decision date: 1982-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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