S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY— 510(k) K872714

Name: FDA 510(k) clearance K872714
Creator: U.S. Food and Drug Administration
Published: 1987-07-21

Substantially Equivalent

Roseburg SA

FDA 510(k) clearance K872714 for S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY, Substantially Equivalent on 1987-07-21. Applicant: Roseburg SA. Device class: 1.

Clearance details

Applicant: Roseburg SA
Product code: Code GBI
Device class: Class 1
Regulation: 21 CFR 878.3800
Advisory panel: General, Plastic Surgery
Date received: 1987-07-10
Decision date: 1987-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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