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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 K961440
Device Name SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH
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 Received04/15/1996
Decision Date 05/31/1996
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
Predetermined Change
Control Plan Authorized		 No
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