EMERGENCY POWER PAC (EMPAC)

Instrument, Vitreous Aspiration And Cutting, Battery-powered

OPTICAL MICRO SYSTEMS, INC.

The following data is part of a premarket notification filed by Optical Micro Systems, Inc. with the FDA for Emergency Power Pac (empac).

Pre-market Notification Details

Device IDK813273
510k NumberK813273
Device Name:EMERGENCY POWER PAC (EMPAC)
ClassificationInstrument, Vitreous Aspiration And Cutting, Battery-powered
Applicant OPTICAL MICRO SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHKP  
CFR Regulation Number886.4150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-20
Decision Date1981-12-31

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