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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, polymeric
510(k) Number K973462
Device Name SOFTFORM FACIAL IMPLANT
Applicant
TISSUE TECHNOLOGIES, INC.
1370 GREEN ST.
SAN FRANCISCO,  CA  94109
Applicant Contact JESSE KRAMER, PH.D
Correspondent
TISSUE TECHNOLOGIES, INC.
1370 GREEN ST.
SAN FRANCISCO,  CA  94109
Correspondent Contact JESSE KRAMER, PH.D
Regulation Number878.3300
Classification Product Code
FTL  
Date Received09/12/1997
Decision Date 11/24/1997
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
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