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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
510(k) Number K061030
Device Name BIOBLANKET SURGICAL MESH
Applicant
KENSEY NASH CORPORATION
735 PENNSYLVANIA DRIVE
EXTON,  PA  19341
Applicant Contact DEBORAH RACIOPPI
Correspondent
KENSEY NASH CORPORATION
735 PENNSYLVANIA DRIVE
EXTON,  PA  19341
Correspondent Contact DEBORAH RACIOPPI
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
OWY   OXB   OXE   OXH   PAI  
PAJ  
Date Received04/14/2006
Decision Date 05/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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