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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 K161370
Device Name Durepair Dura Regeneration Matrix
Applicant
Medtronic Neurosurgery
125 Cremona Dr.
Goleta,  CA  93117
Applicant Contact Manas Lele
Correspondent
Integra Life Sciences Corporation
1100 Campus Rd.
Princeton,  NJ  08540
Correspondent Contact Jacqueline Ferro
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received05/17/2016
Decision Date 11/02/2016
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
Recalls CDRH Recalls
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