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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 K153706
Device Name Insulin Pen Needle
Applicant
STERILANCE MEDICAL (SUZHOU) INC.
68 LITANGHE RD.,
XIANGCHENG
SUZHOU,  CN 215113
Applicant Contact Juanjuan Sun
Correspondent
SHENZHEN JOYANTECH CONSULTING CO., LTD.
NO. 55 SHIZHOU MIDDLE ROAD, NANSHAN DISTRICT
SHENZHEN,  CN GD755
Correspondent Contact Field Fu
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/23/2015
Decision Date 08/29/2016
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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