FDA 510(k) Application Details - K220648

Device Classification Name Driver, Wire, And Bone Drill, Manual

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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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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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