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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 K042072
Device Name CALLOS 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  
Date Received08/02/2004
Decision Date 09/16/2004
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
Recalls CDRH Recalls
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