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FDA 510(k) Application Details - K063438
Device Classification Name
Cement, Bone, Vertebroplasty
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510(K) Number
K063438
Device Name
Cement, Bone, Vertebroplasty
Applicant
TECRES SPA
1700 RESEARCH BOULEVARD
SUITE 220
ROCKVILLE, MD 20850 US
Other 510(k) Applications for this Company
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
11/14/2006
Decision Date
01/17/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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