BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES

Electrosurgical, Cutting & Coagulation & Accessories

BOVIE MEDICAL CORPORATION

The following data is part of a premarket notification filed by Bovie Medical Corporation with the FDA for Bovie Resistick Ii Coated Electrosurgical Electrodes.

Pre-market Notification Details

Device IDK093025
510k NumberK093025
Device Name:BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant BOVIE MEDICAL CORPORATION 5115 Ulmerton Road Clearwater,  FL  33760 -0000
ContactRichard Kozloff
CorrespondentRichard Kozloff
BOVIE MEDICAL CORPORATION 5115 Ulmerton Road Clearwater,  FL  33760 -0000
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-29
Decision Date2009-12-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10607151005716 K093025 000
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10889942241712 K093025 000

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