BTL-899A

Electrosurgical, Cutting & Coagulation & Accessories

BTL Industries Inc.

The following data is part of a premarket notification filed by Btl Industries Inc. with the FDA for Btl-899a.

Pre-market Notification Details

Device IDK213344
510k NumberK213344
Device Name:BTL-899A
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant BTL Industries Inc. 362 Elm Street Marlborough,  MA  01752
ContactDavid Chmel
CorrespondentDavid Chmel
BTL Industries Inc. 362 Elm Street Marlborough,  MA  01752
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-07
Decision Date2022-01-05

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