AMOENA BREAST FORMS— 510(k) K853822

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K853822 for AMOENA BREAST FORMS, Substantially Equivalent on 1985-09-30. Applicant: Coloplast Corp..

Clearance details

Applicant
Coloplast Corp.
Product code
Code GBI
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Marietta, GA, US
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