Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 M And 2.1 M, Megadyne RF Sensor

Apparatus, Exhaust, Surgical

Megadyne Medical Products, Inc.

The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 M And 2.1 M, Megadyne Rf Sensor.

Pre-market Notification Details

Device IDK200250
510k NumberK200250
Device Name:Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 M And 2.1 M, Megadyne RF Sensor
ClassificationApparatus, Exhaust, Surgical
Applicant Megadyne Medical Products, Inc. 11506 S State St Draper,  UT  84020
ContactSharon Sussex
CorrespondentKweku Biney
Ethicon Endo-Surgery, Inc 4545 Creek Road Cincinnati,  OH  45242
Product CodeFYD  
CFR Regulation Number878.5070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-03
Decision Date2020-06-26

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