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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 K203522
Device Name Surn5 Electrosurgical Argon Beam Generator and Accessories
Applicant
Surnic Corporation
480 Apollo St., Suite D
Brea,  CA  92821
Applicant Contact Helen Xie
Correspondent
Surnic Corporation
480 Apollo St., Suite D
Brea,  CA  92821
Correspondent Contact Helen Xie
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/01/2020
Decision Date 02/22/2021
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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