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.. Device class: 1.

Clearance details

Applicant: Coloplast Corp.
Product code: Code KCZ
Device class: Class 1
Regulation: 21 CFR 878.3800
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

Download summary PDF View on FDA.gov ↗

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