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510(k) K180845

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

K180845 is an FDA 510(k) premarket notification submitted by Handpiece Headquarters - Hpr, Inc. for the device "Maxima Electric System". The FDA issued a decision of Substantially Equivalent on July 25, 2019. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200.

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

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FDA data resources