Electrosurgical Accessory

Electrosurgical, Cutting & Coagulation & Accessories

New Deantronics Taiwan Ltd

The following data is part of a premarket notification filed by New Deantronics Taiwan Ltd with the FDA for Electrosurgical Accessory.

Pre-market Notification Details

Device IDK183126
510k NumberK183126
Device Name:Electrosurgical Accessory
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant New Deantronics Taiwan Ltd New Taipei City,  TW 23675
ContactJane Liu
CorrespondentCraig J. Coombs
Coombs Medical Device Consulting, Inc 1193 Sherman St Alameda,  CA  94501
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-13
Decision Date2019-05-08

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