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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 K192542
Device Name Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde
Applicant
Modern Medical Equipment Manufacturing, Ltd.
Flat A, 11/F., Mai Wah Ind. B;Dg., 1-7, Kawi Chung, N.T.,
Hong Kong
Hong Kong,  CN
Applicant Contact Jerry Cheung
Correspondent
Modern Medical Equipment Manufacturing, Ltd.
Flat A, 11/F., Mai Wah Ind. B;Dg., 1-7, Kawi Chung, N.T.,
Hong Kong
Hong Kong,  CN
Correspondent Contact Jerry Cheung
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/16/2019
Decision Date 06/16/2020
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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