Electrosurgical Accessory

Electrode, Electrosurgical, Active, Urological

Dornier MedTech America Inc.

The following data is part of a premarket notification filed by Dornier Medtech America Inc. with the FDA for Electrosurgical Accessory.

Pre-market Notification Details

Device IDK210394
510k NumberK210394
Device Name:Electrosurgical Accessory
ClassificationElectrode, Electrosurgical, Active, Urological
Applicant Dornier MedTech America Inc. 1155 Roberts Blvd, Suite 100 Kennesaw,  GA  30144
ContactJohn Hoffer
CorrespondentJohn Hoffer
Dornier MedTech America Inc. 1155 Roberts Blvd, Suite 100 Kennesaw,  GA  30144
Product CodeFAS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-10
Decision Date2021-05-19

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