PROCEL(TM) DERMALINER GLOVE— 510(k) K931094

Name: FDA 510(k) clearance K931094
Creator: U.S. Food and Drug Administration
Published: 1994-02-14

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K931094 for PROCEL(TM) DERMALINER GLOVE, Substantially Equivalent on 1994-02-14. Applicant: W. L. Gore & Associates, Inc.. Device class: 1.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code LYU
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1993-03-03
Decision date: 1994-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, 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.