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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
Models DRM1011, DRM1013, DRM1022, DRM1033
Device Name DURAGEN SECURE DURAL REGNERATION MATRIX
Original Applicant
INTEGRA LIFESCIENCES
311 enterprise dr.
plainsboro,  NJ  08536
Original Contact aakash jain
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received02/29/2012
Decision Date 06/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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