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FDA 510(k) Application Details - K122322
Device Classification Name
Drill, Bone, Powered
More FDA Info for this Device
510(K) Number
K122322
Device Name
Drill, Bone, Powered
Applicant
MECTRON S.P.A.
PIAZZA ALBANIA 10
ROME 00153 IT
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Contact
ROGER GRAY
Other 510(k) Applications for this Contact
Regulation Number
872.4120
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Classification Product Code
DZI
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More FDA Info for this Product Code
Date Received
08/01/2012
Decision Date
12/06/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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