VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM

Electrosurgical, Cutting & Coagulation & Accessories

MITEK PRODUCTS

The following data is part of a premarket notification filed by Mitek Products with the FDA for Varpr 3.5mm 90 Suction Electrode For Use With Vapr System.

Pre-market Notification Details

Device IDK002422
510k NumberK002422
Device Name:VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant MITEK PRODUCTS 249 VANDERBILT AVE. Norwood,  MA  02062
ContactMary P Legraw
CorrespondentMary P Legraw
MITEK PRODUCTS 249 VANDERBILT AVE. Norwood,  MA  02062
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-08
Decision Date2000-08-31

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