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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, needle
510(k) Number K161566
Device Name DMS Disposable Subdermal Needle Electrodes
Applicant
Daehan Medical Systems Co., Ltd.
250 Okgucheondong-Ro
Siheung City,  KR 15084
Applicant Contact Dong Cheul Kim
Correspondent
Daehan Medical Systems Co., Ltd.
250 Okgucheondong-Ro
Siheung City,  KR 15084
Correspondent Contact Dong Cheul Kim
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received06/06/2016
Decision Date 12/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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