ELMED ESU 300 M/M AND DIGITAL

Electrosurgical, Cutting & Coagulation & Accessories

ELMED, INC.

The following data is part of a premarket notification filed by Elmed, Inc. with the FDA for Elmed Esu 300 M/m And Digital.

Pre-market Notification Details

Device IDK932938
510k NumberK932938
Device Name:ELMED ESU 300 M/M AND DIGITAL
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ELMED, INC. 60 WEST FAY AVE. Addison,  IL  60101
ContactWerner Hausner
CorrespondentWerner Hausner
ELMED, INC. 60 WEST FAY AVE. Addison,  IL  60101
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-06-16
Decision Date1994-05-02

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