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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 K061445
Device Name SURGIMESH WN
Applicant
Aspide Medical
555 Thirteenth St. NW
Columbia Square
Washington,  DC  20004 -1109
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Aspide Medical
555 Thirteenth St. NW
Columbia Square
Washington,  DC  20004 -1109
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number878.3300
Classification Product Code
FTL  
Date Received05/24/2006
Decision Date 02/01/2007
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
Recalls CDRH Recalls
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