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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 K200253
Device Name Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector
Applicant
Ethicon Endo-Surgery
475 Cale C
Guaynabo,  PR  00696
Applicant Contact Emily Nesbitt
Correspondent
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Blue Ash,  OH  45242
Correspondent Contact Emily Nesbitt
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/03/2020
Decision Date 05/27/2020
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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