MENTOR WET-FIELD*II COAGULATOR

Apparatus, Cautery, Radiofrequency, Battery-powered

MENTOR O & O, INC.

The following data is part of a premarket notification filed by Mentor O & O, Inc. with the FDA for Mentor Wet-field*ii Coagulator.

Pre-market Notification Details

Device IDK881001
510k NumberK881001
Device Name:MENTOR WET-FIELD*II COAGULATOR
ClassificationApparatus, Cautery, Radiofrequency, Battery-powered
Applicant MENTOR O & O, INC. 3000 LONGWATER DR. Norwell,  MA  02061 -1672
ContactMark Toma
CorrespondentMark Toma
MENTOR O & O, INC. 3000 LONGWATER DR. Norwell,  MA  02061 -1672
Product CodeHQQ  
CFR Regulation Number886.4100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-09
Decision Date1988-05-13

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