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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 K042911
FOIA Releasable 510(k) K042911
Device Name CEMENTEK LV
Applicant
TEKNIMED SA
1001 OAKWOOD BLVD
ROUND ROCK,  TX  78681
Applicant Contact J.D. WEBB
Correspondent
TEKNIMED SA
1001 OAKWOOD BLVD
ROUND ROCK,  TX  78681
Correspondent Contact J.D. WEBB
Regulation Number888.3045
Classification Product Code
MQV  
Date Received10/21/2004
Decision Date 12/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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