MIS ELECTROSURGICAL ELECTRODES

Electrosurgical, Cutting & Coagulation & Accessories

BEACON LABORATORIES, INC.

The following data is part of a premarket notification filed by Beacon Laboratories, Inc. with the FDA for Mis Electrosurgical Electrodes.

Pre-market Notification Details

Device IDK915788
510k NumberK915788
Device Name:MIS ELECTROSURGICAL ELECTRODES
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant BEACON LABORATORIES, INC. 2150 WEST 6TH AVE., UNIT P Broomfield,  CO  80020
ContactRichard P Fleenor
CorrespondentRichard P Fleenor
BEACON LABORATORIES, INC. 2150 WEST 6TH AVE., UNIT P Broomfield,  CO  80020
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-24
Decision Date1992-03-13

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