MEGA POWER ELECTROSURGICAL GENERATOR

Electrosurgical, Cutting & Coagulation & Accessories

MEGADYNE MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Mega Power Electrosurgical Generator.

Pre-market Notification Details

Device IDK050579
510k NumberK050579
Device Name:MEGA POWER ELECTROSURGICAL GENERATOR
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper,  UT  84020
ContactRonda K Magneson
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-03-07
Decision Date2005-03-24
Summary:summary

NIH GUDID Devices

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