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FDA 510(k) Application Details - K061531
Device Classification Name
Cement, Bone, Vertebroplasty
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510(K) Number
K061531
Device Name
Cement, Bone, Vertebroplasty
Applicant
DFINE, INC.
19450 STEVENS CREEK BLVD.
SUITE 100
CUPERTINO, CA 95014 US
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Contact
ROBERT D POSER
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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
06/02/2006
Decision Date
08/30/2006
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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