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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 K250510
Device Name Sure-Fine Insulin Syringes
Applicant
Shina Med Corporation
455-30, Bogaewonsam-Ro, Bogae-Myeon
Anseong-Si,  KR 17509
Applicant Contact Taejoo Ha
Correspondent
Plusglobal
300, Atwood St.
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number880.5860
Classification Product Code
FMF  
Date Received02/21/2025
Decision Date 10/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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