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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 K191531
Device Name Sure-Fine Insulin Syringes
Applicant
Shina Med Corporation
455-30 Bogaewonsam-Ro, Bogae-Myun
Anseong-Si,  KR 456-871
Applicant Contact Park Sung-soon
Correspondent
Shina Med Corporation
455-30 Bogaewonsam-Ro, Bogae-Myun
Anseong-Si,  KR 456-871
Correspondent Contact Park Sung-soon
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/10/2019
Decision Date 09/06/2019
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
Recalls CDRH Recalls
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