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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 K962496
Device Name SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)
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 Received06/26/1996
Decision Date 09/03/1996
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
Predetermined Change
Control Plan Authorized		 No
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