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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Animal Source, Intraoral
510(k) Number K090919
Device Name KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE
Applicant
Kensey Nash Corp.
735 Pennsylvania Dr.
Exton,  PA  19341
Applicant Contact Alyssa Schwartz
Correspondent
Kensey Nash Corp.
735 Pennsylvania Dr.
Exton,  PA  19341
Correspondent Contact Alyssa Schwartz
Regulation Number872.3930
Classification Product Code
NPL  
Date Received04/01/2009
Decision Date 10/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
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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