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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 K210848
Device Name Sure-Fine Insulin Syringes
Applicant
Shina Med Corporation
455-30, Bogaewonsam-Ro, Bogae-Myeon
Anseong-Si,  KR 17509
Applicant Contact Jeong Ho Ryu
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt Suite 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/22/2021
Decision Date 03/01/2022
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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