OSTOMY IRRIGATION SET— 510(k) K121833

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K121833 for OSTOMY IRRIGATION SET, Substantially Equivalent on 2012-07-16. Applicant: Coloplast A/S.

Clearance details

Applicant: Coloplast A/S
Product code: Code EXD
Advisory panel: Gastroenterology, Urology
Date received: 2012-06-22
Decision date: 2012-07-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, US

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