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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 K120600
Device Name DURAGEN SECURE DURAL REGNERATION MATRIX
Applicant
Integra Life Sciences
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact AAKASH JAIN
Correspondent
Integra Life Sciences
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact AAKASH JAIN
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received02/28/2012
Decision Date 06/15/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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