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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 K152879
Device Name Sure-Fine Insulin Syringes
Applicant
Shina Med Corporation
455-30, Bogawonsam-Ro Bogae-Myun
Anseong-Si,  KR 456-871
Applicant Contact SUNG-SOON PARK
Correspondent
LK Consulting Group USA, Inc.
2651 E. Chapman Ave., Suite 110
Fullerton,  CA  92831
Correspondent Contact PRISCILLA CHUNG
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/30/2015
Decision Date 09/09/2016
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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