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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K012955
Device Name COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER
Applicant
Bioform, Inc.
4133 Ct.ney Rd., #10
Franksville,  WI  53126
Applicant Contact VICTOR M BOWERS
Correspondent
Bioform, Inc.
4133 Ct.ney Rd., #10
Franksville,  WI  53126
Correspondent Contact VICTOR M BOWERS
Regulation Number878.4300
Classification Product Code
NEU  
Subsequent Product Code
GDW  
Date Received09/04/2001
Decision Date 10/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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