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FDA 510(k) Application Details - K132620
Device Classification Name
Cement, Bone, Vertebroplasty
More FDA Info for this Device
510(K) Number
K132620
Device Name
Cement, Bone, Vertebroplasty
Applicant
PAN MEDICAL LTD
BARNETT WAY, BARNWOOD
GLOUCESTER, GLOUCESTERSHIRE GL4 3RT GB
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Contact
JENNIE BUDDING
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
08/21/2013
Decision Date
04/16/2014
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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