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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 K051784
Device Name OSTEOVATION CMF BONE VOID FILLER
Applicant
Skeletal Kinetics, LLC
10201 Bubb Rd.
Cupertino,  CA  95014 -4167
Applicant Contact DURAN YETKINLER
Correspondent
Skeletal Kinetics, LLC
10201 Bubb Rd.
Cupertino,  CA  95014 -4167
Correspondent Contact DURAN YETKINLER
Regulation Number882.5300
Classification Product Code
GXP  
Subsequent Product Code
FWP  
Date Received07/01/2005
Decision Date 07/20/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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