AMOENA AFFINITY MODEL #802— 510(k) K915382

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K915382 for AMOENA AFFINITY MODEL #802, Substantially Equivalent on 1992-01-14. Applicant: Coloplast Corp..

Clearance details

Applicant: Coloplast Corp.
Product code: Code KCZ
Advisory panel: General, Plastic Surgery
Date received: 1991-11-29
Decision date: 1992-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

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