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FDA 510(k) Application Details - K062452
Device Classification Name
Cement, Bone, Vertebroplasty
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510(K) Number
K062452
Device Name
Cement, Bone, Vertebroplasty
Applicant
TECRES SPA
1700 RESEARCH BOULEVARD
SUITE 220
ROCKVILLE, MD 20850 US
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Contact
CHRISTINE BRAUER
Other 510(k) Applications for this Contact
Regulation Number
888.3027
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Classification Product Code
NDN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/22/2006
Decision Date
09/21/2006
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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