SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM— 510(k) K070939

Name: FDA 510(k) clearance K070939
Creator: U.S. Food and Drug Administration
Published: 2007-06-01

Substantially Equivalent

Coloplast Manufacturing Us, LLC

FDA 510(k) clearance K070939 for SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM, Substantially Equivalent on 2007-06-01. Applicant: Coloplast Manufacturing Us, LLC. Device class: 2.

Clearance details

Applicant: Coloplast Manufacturing Us, LLC
Product code: Code FCM
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2007-04-04
Decision date: 2007-06-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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