O.M.S. GUILLOTINE CUTTER

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 O.m.s. Guillotine Cutter.

Pre-market Notification Details

Device IDK844374
510k NumberK844374
Device Name:O.M.S. GUILLOTINE CUTTER
ClassificationInstrument, Vitreous Aspiration And Cutting, Ac-powered
Applicant OPTICAL MICRO SYSTEMS, INC. 8 ELECTRONICS AVE. Danvers,  MA  01923
ContactGerald A Clay
CorrespondentGerald A 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 Received1984-11-13
Decision Date1984-12-11

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