HOLLISTER RETRACTED PENIS POUCH— 510(k) K970443

Name: FDA 510(k) clearance K970443
Creator: U.S. Food and Drug Administration
Published: 1997-02-25

Substantially Equivalent

Hollister, Inc.

FDA 510(k) clearance K970443 for HOLLISTER RETRACTED PENIS POUCH, Substantially Equivalent on 1997-02-25. Applicant: Hollister, Inc.. Device class: 1.

Clearance details

Applicant: Hollister, Inc.
Product code: Code EXI
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1997-02-05
Decision date: 1997-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Libertyville, IL, US

Download summary PDF View on FDA.gov ↗

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