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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K210929
Device Name MagiCath II
Woo Young Medical Co., Ltd.
98, Sangsin2-gil, Jincheon-eup
Jincheon-gun,  KR 27846
Applicant Contact Jenny Cho
MTech Group
7505 Fannin St. Ste 610
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number880.5200
Classification Product Code
Date Received03/29/2021
Decision Date 09/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No