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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K181758
Device Name ELRA Electrode
Applicant
Starmed Co., Ltd.
B-Dong, 4f, 158, Haneulmaeul-Ro, Ilsandong-Gu
Goyang-Si,  KR 10355
Applicant Contact Jun-Young Jung
Correspondent
Starmed Co., Ltd.
B-Dong, 4f, 158, Haneulmaeul-Ro, Ilsandong-Gu
Goyang-Si,  KR 10355
Correspondent Contact Jun-Young Jung
Regulation Number876.4300
Classification Product Code
KNS  
Date Received07/02/2018
Decision Date 04/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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