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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Methyl Methacrylate For Cranioplasty
510(k) Number K072601
Device Name OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
Applicant
Osteosymbionics, LLC
1768 E 25th St.
Cleveland,  OH  44114
Applicant Contact CYNTHIA M BROGAN
Correspondent
Osteosymbionics, LLC
1768 E 25th St.
Cleveland,  OH  44114
Correspondent Contact CYNTHIA M BROGAN
Regulation Number882.5300
Classification Product Code
GXP  
Subsequent Product Code
GXN  
Date Received09/14/2007
Decision Date 12/10/2007
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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