MICROSCOPE MODEL OM-U

Microscope, Surgical

JEDMED INSTRUMENT CO.

The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Microscope Model Om-u.

Pre-market Notification Details

Device IDK802904
510k NumberK802904
Device Name:MICROSCOPE MODEL OM-U
ClassificationMicroscope, Surgical
Applicant JEDMED INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEPT  
CFR Regulation Number878.4700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-11-17
Decision Date1981-02-04

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