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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 K813416
Device Name EXTERNAL BREAST PROSTHESIS
Applicant
SURGICAL APPLIANCE INDUSTRIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SURGICAL APPLIANCE INDUSTRIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.3800
Classification Product Code
GBI  
Date Received12/07/1981
Decision Date 01/18/1982
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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