ELECTROSURGICAL MONOPOLAR HANDSWITCHING PENCIL W/REMOVABLE BLADE

Electrosurgical, Cutting & Coagulation & Accessories

DEBUSK TECHNOLOGY CORP.

The following data is part of a premarket notification filed by Debusk Technology Corp. with the FDA for Electrosurgical Monopolar Handswitching Pencil W/removable Blade.

Pre-market Notification Details

Device IDK940909
510k NumberK940909
Device Name:ELECTROSURGICAL MONOPOLAR HANDSWITCHING PENCIL W/REMOVABLE BLADE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant DEBUSK TECHNOLOGY CORP. 200 DEBUSK LN. Powell,  TN  37849
ContactDebra F Manning
CorrespondentDebra F Manning
DEBUSK TECHNOLOGY CORP. 200 DEBUSK LN. Powell,  TN  37849
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-23
Decision Date1994-03-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.