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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 K041493
Device Name CEMENTEK
Original Applicant
TEKNIMED SA
1001 oakwood blvd
round rock,  TX  78681
Original Contact j.d. webb
Regulation Number888.3045
Classification Product Code
MQV  
Date Received06/04/2004
Decision Date 08/19/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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