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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
Recalls CDRH Recalls
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