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FDA 510(k) Application Details - K220648
Device Classification Name
Driver, Wire, And Bone Drill, Manual
More FDA Info for this Device
510(K) Number
K220648
Device Name
Driver, Wire, And Bone Drill, Manual
Applicant
VHA DEAN
810 Vermont Ave NW
Washington, DC 20420 US
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Contact
Beth Ripley
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Regulation Number
872.4120
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Classification Product Code
DZJ
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More FDA Info for this Product Code
Date Received
03/07/2022
Decision Date
08/11/2022
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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