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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 K141587
Device Name E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER
Applicant
Megadyne Medical Products, Inc.
11506 S. State St.
Draper,  UT  84020
Applicant Contact RONDA MAGNESON
Correspondent
Megadyne Medical Products, Inc.
11506 S. State St.
Draper,  UT  84020
Correspondent Contact RONDA MAGNESON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/13/2014
Decision Date 02/18/2015
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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