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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K051123
Device Name CALLOS IMPACT AND INJECT 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 Number888.3045
Classification Product Code
MQV  
Date Received05/03/2005
Decision Date 06/03/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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