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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K222417
Device Name Shina Safety Needle
Applicant
Shina Corporation
8-26, Bojeokdong-Gil
Gongju,  KR 32533
Applicant Contact Seunggi Jeon
Correspondent
Shina Corporation
8-26, Bojeokdong-Gil
Gongju,  KR 32533
Correspondent Contact Seunggi Jeon
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/10/2022
Decision Date 03/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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