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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 K040669
Device Name CERAFORM BONE VOID FILLER
Original Applicant
TEKNIMED SA
1001 oakwood blvd
round rock,  TX  78681
Original Contact j.d. webb
Regulation Number888.3045
Classification Product Code
MQV  
Date Received03/15/2004
Decision Date 05/03/2004
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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