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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
Recalls CDRH Recalls
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