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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, exhaust, surgical
510(k) Number K200250
Device Name Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor
Applicant
Megadyne Medical Products, Inc.
11506 S State St
Draper,  UT  84020
Applicant Contact Sharon Sussex
Correspondent
Ethicon Endo-Surgery, Inc
4545 Creek Road
Cincinnati,  OH  45242
Correspondent Contact Kweku Biney
Regulation Number878.5070
Classification Product Code
FYD  
Date Received02/03/2020
Decision Date 06/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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