MAID MENTOR ASPIRATION/IRRIGATION DEVRO

Instrument, Vitreous Aspiration And Cutting, Ac-powered

MENTOR O & O, INC.

The following data is part of a premarket notification filed by Mentor O & O, Inc. with the FDA for Maid Mentor Aspiration/irrigation Devro.

Pre-market Notification Details

Device IDK853382
510k NumberK853382
Device Name:MAID MENTOR ASPIRATION/IRRIGATION DEVRO
ClassificationInstrument, Vitreous Aspiration And Cutting, Ac-powered
Applicant MENTOR O & O, INC. SOUTH SHORE PARK Hingham,  MA  02043
ContactDavid M Link
CorrespondentDavid M Link
MENTOR O & O, INC. SOUTH SHORE PARK Hingham,  MA  02043
Product CodeHQE  
CFR Regulation Number886.4150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-08-12
Decision Date1985-10-04

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