BIPOLAR FORCEPS

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 Bipolar Forceps.

Pre-market Notification Details

Device IDK953479
510k NumberK953479
Device Name:BIPOLAR FORCEPS
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper,  UT  84020
ContactDrew D Weaver
CorrespondentDrew D Weaver
MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper,  UT  84020
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-24
Decision Date1995-10-12

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