510(k) K180845

Maxima Electric System by Handpiece Headquarters - Hpr, Inc. — Product Code EBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2019
Date Received
April 2, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Foot, Handpiece And Cord
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type