SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)


Device Classification Name

material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction

510(k) Number K021889
Device Name SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)
Original Applicant
SURGICAL TECHNOLOGY LABORATORIES, INC.
1588 east 40th st.
cleveland, 
OH 
44103

Original Contact cameron j fordyce
Regulation Number 878.3500
Classification Product Code
KKY  
Date Received 06/07/2002
Decision Date 10/16/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No