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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, External Aesthetic Restoration, Used With Adhesive
510(k) Number K872714
Device Name S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY
Applicant
ROSEBURG SA
SUITE 120 CANAL SQUARE
1054 31ST STREET NW
WASHINGTON,  DC  20007
Applicant Contact DARIENNE MOYER
Correspondent
ROSEBURG SA
SUITE 120 CANAL SQUARE
1054 31ST STREET NW
WASHINGTON,  DC  20007
Correspondent Contact DARIENNE MOYER
Regulation Number878.3800
Classification Product Code
GBI  
Date Received07/10/1987
Decision Date 07/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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