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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 K113186
Device Name STERILE INSULIN PEN NEEDLE
Original Applicant
SHINA CORP.
691-1, boheung-ri
useong-myeon, gongju-si
chungchengnam-do,  KR 314864
Original Contact jiseop jeong
Regulation Number880.5570
Classification Product Code
FMI  
Date Received10/28/2011
Decision Date 04/12/2012
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
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