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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 K123723
Device Name SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
Applicant
SYNTHES
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact ALAN T HALEY
Correspondent
SYNTHES
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact ALAN T HALEY
Regulation Number882.5320
Classification Product Code
GWO  
Subsequent Product Code
GXR  
Date Received12/04/2012
Decision Date 09/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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