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FDA 510(k) Application Details - K080873
Device Classification Name
Cement, Bone, Vertebroplasty
More FDA Info for this Device
510(K) Number
K080873
Device Name
Cement, Bone, Vertebroplasty
Applicant
TEKNIMED SA
1001 OAKWOOD BLVD
ROUND ROCK, TX 78681 US
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Contact
J.D. WEBB
Other 510(k) Applications for this Contact
Regulation Number
888.3027
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Classification Product Code
NDN
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More FDA Info for this Product Code
Date Received
03/31/2008
Decision Date
08/28/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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