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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 K160575
Device Name CareSens Pen Needle, Softip Pen Needle
Applicant
Yidobio, Inc.
#3-1, 59-12, Dong4-Gil, Hyangnam-Eup
Hwaseong-Si,  KR 18624
Applicant Contact KYUNG HEE YOON
Correspondent
Yidobio, Inc.
#3-1, 59-12, Dong4-Gil, Hyangnam-Eup
Hwaseong-Si,  KR 18624
Correspondent Contact KYUNG HEE YOON
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/01/2016
Decision Date 09/07/2016
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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