DWYER EYE SYSTEMS ASPIRATION UNIT

Instrument, Vitreous Aspiration And Cutting, Ac-powered

SPECTRACARE, INC.

The following data is part of a premarket notification filed by Spectracare, Inc. with the FDA for Dwyer Eye Systems Aspiration Unit.

Pre-market Notification Details

Device IDK913261
510k NumberK913261
Device Name:DWYER EYE SYSTEMS ASPIRATION UNIT
ClassificationInstrument, Vitreous Aspiration And Cutting, Ac-powered
Applicant SPECTRACARE, INC. C/O MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro,  MA  02703
ContactLynne Aronson
CorrespondentLynne Aronson
SPECTRACARE, INC. C/O MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro,  MA  02703
Product CodeHQE  
CFR Regulation Number886.4150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-23
Decision Date1992-01-30

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