COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)— 510(k) K971597

Name: FDA 510(k) clearance K971597
Creator: U.S. Food and Drug Administration
Published: 1997-07-29

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K971597 for COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903), Substantially Equivalent on 1997-07-29. Applicant: Coloplast Corp.. Device class: 1.

Clearance details

Applicant: Coloplast Corp.
Product code: Code NAE
Device class: Class 1
Regulation: 21 CFR 878.4022
Advisory panel: General, Plastic Surgery
Date received: 1997-05-01
Decision date: 1997-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

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