VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM

Arthroscope

MITEK PRODUCTS

The following data is part of a premarket notification filed by Mitek Products with the FDA for Vapr Tc Electrode For Use With Vapr Ii Electrosurgical System.

Pre-market Notification Details

Device IDK002402
510k NumberK002402
Device Name:VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM
ClassificationArthroscope
Applicant MITEK PRODUCTS 249 VANDERBILT AVE. Norwood,  MA  02062
ContactMary P Legaw
CorrespondentMary P Legaw
MITEK PRODUCTS 249 VANDERBILT AVE. Norwood,  MA  02062
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-07
Decision Date2000-08-31

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