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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K212635
Device Name Sofjec
Applicant
Hwajin Medical Co., Ltd.
20, Seongsimwon-Gil, Seongnam-Myeon, Dongnam-Gu
Cheonan-Si,  KR 31244
Applicant Contact Jeon Sung Hun
Correspondent
Hwajin Medical Co., Ltd.
20, Seongsimwon-Gil, Seongnam-Myeon, Dongnam-Gu
Cheonan-Si,  KR 31244
Correspondent Contact Jeon Sung Hun
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Codes
FMI   MEG  
Date Received08/19/2021
Decision Date 02/13/2023
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
Predetermined Change
Control Plan Authorized		 No
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