EXILIS, MODEL 5000

Electrosurgical, Cutting & Coagulation & Accessories

BTL INDUSTRIES LTD

The following data is part of a premarket notification filed by Btl Industries Ltd with the FDA for Exilis, Model 5000.

Pre-market Notification Details

Device IDK092191
510k NumberK092191
Device Name:EXILIS, MODEL 5000
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant BTL INDUSTRIES LTD 1705 S. CAPITAL OF TEXAS HWY. SUITE 500 Austin,  TX  78746
ContactRichard Vincins
CorrespondentRichard Vincins
BTL INDUSTRIES LTD 1705 S. CAPITAL OF TEXAS HWY. SUITE 500 Austin,  TX  78746
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-21
Decision Date2009-11-25
Summary:summary

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