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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dura Substitute
510(k) Number K072207
Device Name DURAGEN XS DURAL REGENERATION MATRIX
Applicant
Integra Lifesciences Corp.
311c Enterprise Dr.
Plainsboro,  NJ  08536
Applicant Contact PETER ALLAN
Correspondent
Integra Lifesciences Corp.
311c Enterprise Dr.
Plainsboro,  NJ  08536
Correspondent Contact PETER ALLAN
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received08/08/2007
Decision Date 08/23/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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