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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 K031826
Device Name TRIHA +
Applicant
TEKNIMED SA
1001 OAKWOOD BLVD
ROUNDROCK,  TX  78681
Applicant Contact J. D WEBB
Correspondent
TEKNIMED SA
1001 OAKWOOD BLVD
ROUNDROCK,  TX  78681
Correspondent Contact J. D WEBB
Regulation Number888.3045
Classification Product Code
MQV  
Date Received06/13/2003
Decision Date 11/28/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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