FDA 510(k) Application Details - K172164

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

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510(K) Number K172164
Device Name Driver, Wire, And Bone Drill, Manual
Applicant Propel Orthodontics LLC
394 South Abbott Ave
Milpitas, CA 95035 US
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Contact Bryce Way
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Regulation Number 872.4120

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Classification Product Code DZJ
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Date Received 07/18/2017
Decision Date 01/17/2018
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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