FDA 510(k) Application Details - K180845

Device Classification Name	Controller, Foot, Handpiece And Cord   More FDA Info for this Device
510(K) Number	K180845
Device Name	Controller, Foot, Handpiece And Cord
Applicant	Handpiece Headquarters - HPR Inc. 620 S. Placentia Avenue Placentia, CA 92870 US Other 510(k) Applications for this Company
Contact	Timothy Ropchan Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/2018
Decision Date	07/25/2019
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