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FDA 510(k) Application Details - K102397
Device Classification Name
Cement, Bone, Vertebroplasty
More FDA Info for this Device
510(K) Number
K102397
Device Name
Cement, Bone, Vertebroplasty
Applicant
Medtronic
1221 CROSSMAN AVE.
SUNNYVALE, CA 94089 US
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Contact
MARY ROSE
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
08/24/2010
Decision Date
02/28/2011
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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