COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER— 510(k) K962384

Name: FDA 510(k) clearance K962384
Creator: U.S. Food and Drug Administration
Published: 1996-07-15

Substantially Equivalent

Sierra Laboratories, Inc.

FDA 510(k) clearance K962384 for COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER, Substantially Equivalent on 1996-07-15. 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: 1996-06-20
Decision date: 1996-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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K931156 — CONE CATH1993-07-01
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