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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, Non-Alterable
510(k) Number K133082
Device Name OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
Applicant
Osteosymbionics, LLC
1768 E. 25th St.
Suite 316
Cleveland,  OH  44114
Applicant Contact NICHOLAS WLKINS
Correspondent
Osteosymbionics, LLC
1768 E. 25th St.
Suite 316
Cleveland,  OH  44114
Correspondent Contact NICHOLAS WLKINS
Regulation Number882.5330
Classification Product Code
GXN  
Date Received09/30/2013
Decision Date 05/20/2014
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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