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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 K043427
Device Name DURAGEN II DURAL REGENERATION MATRIX
Applicant
Integra Lifesciences Corp.
105 Morgan Ln.
Plainsboro,  NJ  08536
Applicant Contact DIANA M BORDON
Correspondent
Integra Lifesciences Corp.
105 Morgan Ln.
Plainsboro,  NJ  08536
Correspondent Contact DIANA M BORDON
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received12/13/2004
Decision Date 01/12/2005
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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