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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 K050332
Device Name SURGI-WRAP MAST BIORESORBABLE SHEET
Applicant
MAST BIOSURGERY USA INC.
6749 top gun st., suite c
san diego,  CA  92121
Contact kenneth k kleinhenz
Regulation Number878.3300
Classification Product Code
FTL  
Date Received02/10/2005
Decision Date 05/27/2005
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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