Electrosurgical, Cutting & Coagulation & Accessories


The following data is part of a premarket notification filed by Btl with the FDA for Btl-785f.

Pre-market Notification Details

Device IDK193201
510k NumberK193201
Device Name:BTL-785F
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant BTL 362 Elm Street Marlborough,  MA  01752
ContactDavid Chmel
CorrespondentDavid Chmel
BTL 362 Elm Street Marlborough,  MA  01752
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-20
Decision Date2020-08-21

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