BLOOD POOL & SUBVETINAL FLUID ASPIRATOR

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 Blood Pool & Subvetinal Fluid Aspirator.

Pre-market Notification Details

Device IDK813274
510k NumberK813274
Device Name:BLOOD POOL & SUBVETINAL FLUID ASPIRATOR
ClassificationInstrument, Vitreous Aspiration And Cutting, Ac-powered
Applicant OPTICAL MICRO SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHQE  
CFR Regulation Number886.4150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-23
Decision Date1982-02-05

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