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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, breast, external, used with adhesive
510(k) Number K896533
Device Name SPENCO BREAST FORMS
Applicant
SPENCO MEDICAL CORP.
P.O. BOX 2501
WACO,  TX  76702
Applicant Contact JAMES E MCGOWAN
Correspondent
SPENCO MEDICAL CORP.
P.O. BOX 2501
WACO,  TX  76702
Correspondent Contact JAMES E MCGOWAN
Regulation Number878.3800
Classification Product Code
KCZ  
Date Received11/14/1989
Decision Date 12/13/1989
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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