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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 K253112
Device Name Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
Applicant
Hlb Lifescience Co., Ltd.
122-39, Gieopdanji-Ro, Gongdo-Eup
Anseong-Si,  KR 17551
Applicant Contact Jiwon Han
Correspondent
Mediguide, Inc.
#410, 17, Deogan-Ro 104beon-Gil
Gwangmyeong-Si,  KR 14353
Correspondent Contact Yongjun Lee
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Codes
FMI   QNQ  
Date Received09/24/2025
Decision Date 05/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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