ELECTRIC I/V POLE OR EIVP2

Device, Irrigation, Ocular Surgery

OPTICAL MICRO SYSTEMS, INC.

The following data is part of a premarket notification filed by Optical Micro Systems, Inc. with the FDA for Electric I/v Pole Or Eivp2.

Pre-market Notification Details

Device IDK935003
510k NumberK935003
Device Name:ELECTRIC I/V POLE OR EIVP2
ClassificationDevice, Irrigation, Ocular Surgery
Applicant OPTICAL MICRO SYSTEMS, INC. 300 WILLOW ST. SOUTH North Andover,  MA  01845
ContactRonald Luich
CorrespondentRonald Luich
OPTICAL MICRO SYSTEMS, INC. 300 WILLOW ST. SOUTH North Andover,  MA  01845
Product CodeKYG  
CFR Regulation Number886.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-19
Decision Date1994-01-25

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