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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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