FDA 510(k) Application Details - K183018

Device Classification Name

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510(K) Number K183018
Device Name VPro5
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

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Classification Product Code OYH
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Date Received 10/31/2018
Decision Date 11/01/2019
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

FDA Source Information for K183018


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