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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 K002071
Device Name SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES
Applicant
TISSUE TECHNOLOGIES, INC.
1370 GREEN ST.
SAN FRANCISO,  CA  94109
Applicant Contact JESSE KRAMER
Correspondent
TISSUE TECHNOLOGIES, INC.
1370 GREEN ST.
SAN FRANCISO,  CA  94109
Correspondent Contact JESSE KRAMER
Regulation Number878.3300
Classification Product Code
FTL  
Date Received07/07/2000
Decision Date 07/24/2000
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
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