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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 K964857
Device Name RAPISEAL PATCH
Applicant
FUSION MEDICAL TECHNOLOGIES, INC.
1615 PLYMOUTH ST.
MOUNTAIN VIEW,  CA  94043
Applicant Contact DEBERA BROWN
Correspondent
FUSION MEDICAL TECHNOLOGIES, INC.
1615 PLYMOUTH ST.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact DEBERA BROWN
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/04/1996
Decision Date 02/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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