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510(k) K233958

hekaDrill by Zethon, Ltd. — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2024
Date Received
December 15, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device Class
Class II
Regulation Number
874.4250
Review Panel
EN
Submission Type

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