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510(k) K243911

HPR Cordless Hygiene Handpiece by Handpiece Headquarters — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2024
Date Received
December 19, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Handpiece, Direct Drive, Ac-Powered
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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