ELECTROSURGICAL PENCIL

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 Electrosurgical Pencil.

Pre-market Notification Details

Device IDK904808
510k NumberK904808
Device Name:ELECTROSURGICAL PENCIL
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant MEGADYNE MEDICAL PRODUCTS, INC. 6202 STRATLER ST. Murray,  UT  84107
ContactDrew D Weaver
CorrespondentDrew D Weaver
MEGADYNE MEDICAL PRODUCTS, INC. 6202 STRATLER ST. Murray,  UT  84107
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-10-24
Decision Date1991-01-04

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