HekaDrill

Motor, Drill, Electric

Zethon Ltd

The following data is part of a premarket notification filed by Zethon Ltd with the FDA for Hekadrill.

Pre-market Notification Details

Device IDK193630
510k NumberK193630
Device Name:HekaDrill
ClassificationMotor, Drill, Electric
Applicant Zethon Ltd 2 Halton Brook Business Park Aylesbury,  GB Hp22 5wf
ContactFaith Green
CorrespondentFaith Green
Zethon Ltd 2 Halton Brook Business Park Aylesbury,  GB Hp22 5wf
Product CodeHBC  
Subsequent Product CodeERL
Subsequent Product CodeHBB
Subsequent Product CodeHBE
Subsequent Product CodeHSZ
CFR Regulation Number882.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-26
Decision Date2021-04-09

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