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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction
510(k) Number K021889
Device Name SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)
Applicant
SURGICAL TECHNOLOGY LABORATORIES, INC.
1588 EAST 40TH ST.
CLEVELAND,  OH  44103
Applicant Contact CAMERON J FORDYCE
Correspondent
SURGICAL TECHNOLOGY LABORATORIES, INC.
1588 EAST 40TH ST.
CLEVELAND,  OH  44103
Correspondent Contact CAMERON J FORDYCE
Regulation Number878.3500
Classification Product Code
KKY  
Date Received06/07/2002
Decision Date 10/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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