CONQUEST MALE CONTINENCE SYSTEM— 510(k) K942941

Name: FDA 510(k) clearance K942941
Creator: U.S. Food and Drug Administration
Published: 1995-03-17

Substantially Equivalent

Convatec, A Bristol-Myers Squibb Co.

FDA 510(k) clearance K942941 for CONQUEST MALE CONTINENCE SYSTEM, Substantially Equivalent on 1995-03-17. Applicant: Convatec, A Bristol-Myers Squibb Co.. Device class: 1.

Clearance details

Applicant: Convatec, A Bristol-Myers Squibb Co.
Product code: Code EXJ
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1994-06-22
Decision date: 1995-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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K962900 — SELF RETAINING MALE EXTERNAL URINARY CATHETER1996-09-16

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