Home / 510(k) Clearances / K193630

510(k) K193630

hekaDrill by Zethon, Ltd. — Product Code HBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2021
Date Received
December 26, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Electric
Device Class
Class II
Regulation Number
882.4360
Review Panel
NE
Submission Type

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