ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITAL

Electrosurgical, Cutting & Coagulation & Accessories

ELMED, INC.

The following data is part of a premarket notification filed by Elmed, Inc. with the FDA for Electrosurgical Units Esu 30, 70, 70 B, 70 Digital.

Pre-market Notification Details

Device IDK915731
510k NumberK915731
Device Name:ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 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 Received1991-12-20
Decision Date1992-11-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842180163263 K915731 000
00842180166059 K915731 000
00198506003196 K915731 000
00198506001130 K915731 000
00198506059384 K915731 000

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