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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 K122049
Device Name NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM
Applicant
Kinamed, Inc.
820 Flynn Rd.
Camarillo,  CA  93012
Applicant Contact HEATHER NEELY
Correspondent
Kinamed, Inc.
820 Flynn Rd.
Camarillo,  CA  93012
Correspondent Contact HEATHER NEELY
Regulation Number882.5320
Classification Product Code
GWO  
Subsequent Product Codes
GXR   HBW  
Date Received07/12/2012
Decision Date 04/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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