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FDA 510(k) Application Details - K171958
Device Classification Name
Drill, Bone, Powered
More FDA Info for this Device
510(K) Number
K171958
Device Name
Drill, Bone, Powered
Applicant
Mectron SPA
Via Loreto 15
Carasco 16042 IT
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Contact
Franco Zunino
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
06/29/2017
Decision Date
01/12/2018
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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