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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K193145
Device Name Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch
Applicant
Megadyne Medical Products, Inc.
11506 S. State St.
Draper,  UT  84020
Applicant Contact Sharon Sussex
Correspondent
Ethicon Endo-Surgery, LLC
4545 Creek Rd.
Blue Ash,  OH  45242
Correspondent Contact Kweku Biney
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/13/2019
Decision Date 03/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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