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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 K043259
Device Name BIOBLANKET SURGICAL MESH
Applicant
KENSEY NASH CORP.
55 EAST UWCHLAN AVE.
EXTON,  PA  19341
Applicant Contact DEBORAH RACIOPPI
Correspondent
KENSEY NASH CORP.
55 EAST UWCHLAN AVE.
EXTON,  PA  19341
Correspondent Contact DEBORAH RACIOPPI
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
OWY   OXB   OXE   OXH   PAI  
PAJ  
Date Received11/24/2004
Decision Date 08/15/2005
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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