COLOPLAST OSTOMY ROD, MODEL 12814— 510(k) K052229

Name: FDA 510(k) clearance K052229
Creator: U.S. Food and Drug Administration
Published: 2006-10-13

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K052229 for COLOPLAST OSTOMY ROD, MODEL 12814, Substantially Equivalent on 2006-10-13. Applicant: Coloplast Corp.. Device class: 2.

Clearance details

Applicant: Coloplast Corp.
Product code: Code EZP
Device class: Class 2
Regulation: 21 CFR 876.4270
Advisory panel: Gastroenterology, Urology
Date received: 2005-08-16
Decision date: 2006-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Mankato, MN, US

Download summary PDF View on FDA.gov ↗

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