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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, cranioplasty, preformed, alterable
510(k) Number K140462
Device Name MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
Applicant
SYNTHES (USA) PRODUCTS LLC
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Applicant Contact ALAN T HALEY
Correspondent
SYNTHES (USA) PRODUCTS LLC
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Correspondent Contact ALAN T HALEY
Regulation Number882.5320
Classification Product Code
GWO  
Date Received02/24/2014
Decision Date 06/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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