ELLA BREAST FORM— 510(k) K904085

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K904085 for ELLA BREAST FORM, Substantially Equivalent on 1990-10-31. Applicant: Coloplast A/S.

Clearance details

Applicant: Coloplast A/S
Product code: Code KCZ
Advisory panel: General, Plastic Surgery
Date received: 1990-09-05
Decision date: 1990-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Woth, TX, US

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