COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER— 510(k) K962413

Name: FDA 510(k) clearance K962413
Creator: U.S. Food and Drug Administration
Published: 1996-07-15

Substantially Equivalent

Sierra Laboratories, Inc.

FDA 510(k) clearance K962413 for COMFORT CATH SPECIAL SELF ADHERING 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: 1996-06-21
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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K963265 — PROSYS SAMEC LA1996-10-25
K962900 — SELF RETAINING MALE EXTERNAL URINARY CATHETER1996-09-16

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K962384 — COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER1996-07-15
K934266 — COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER1994-04-19
K934052 — ALPINE REUSABLE LEG BAGS1994-01-07
K931156 — CONE CATH1993-07-01
K901000 — URO TEX URINALS1990-03-26

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