ASPIRATION REVERSAL CONTROL (ARC) MODULE

Instrument, Vitreous Aspiration And Cutting, Ac-powered

OPTICAL MICRO SYSTEMS, INC.

The following data is part of a premarket notification filed by Optical Micro Systems, Inc. with the FDA for Aspiration Reversal Control (arc) Module.

Pre-market Notification Details

Device IDK870068
510k NumberK870068
Device Name:ASPIRATION REVERSAL CONTROL (ARC) MODULE
ClassificationInstrument, Vitreous Aspiration And Cutting, Ac-powered
Applicant OPTICAL MICRO SYSTEMS, INC. 8 ELECTRONICS AVE. Danvers,  MA  01923
ContactGerald Clay
CorrespondentGerald Clay
OPTICAL MICRO SYSTEMS, INC. 8 ELECTRONICS AVE. Danvers,  MA  01923
Product CodeHQE  
CFR Regulation Number886.4150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-01-08
Decision Date1987-02-12

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