GORE-TEX BARRIER SURG. DRAPES & GOWNS— 510(k) K822641

Name: FDA 510(k) clearance K822641
Creator: U.S. Food and Drug Administration
Published: 1983-01-07

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K822641 for GORE-TEX BARRIER SURG. DRAPES & GOWNS, Substantially Equivalent on 1983-01-07. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1982-09-01
Decision date: 1983-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.