COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER— 510(k) K934266

Name: FDA 510(k) clearance K934266
Creator: U.S. Food and Drug Administration
Published: 1994-04-19

Substantially Equivalent

Sierra Laboratories, Inc.

FDA 510(k) clearance K934266 for COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER, Substantially Equivalent on 1994-04-19. Applicant: Sierra Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Sierra Laboratories, Inc.
Product code: Code EXJ
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1993-08-31
Decision date: 1994-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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K934052 — ALPINE REUSABLE LEG BAGS1994-01-07
K931156 — CONE CATH1993-07-01
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