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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 K041923
Device Name BIOBLANKET
Applicant
Kensey Nash Corp.
55 E. Uwchlan Ave.
Exton,  PA  19341
Applicant Contact DEBORAH RACIOPPI
Correspondent
Kensey Nash Corp.
55 E. Uwchlan Ave.
Exton,  PA  19341
Correspondent Contact DEBORAH RACIOPPI
Regulation Number878.3300
Classification Product Code
FTM  
Date Received07/16/2004
Decision Date 09/08/2004
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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