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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 K133058
Device Name INSULIN PEN NEEDLE
Applicant
Wenzhou Wuzhou Import & Export Co., Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Applicant Contact Diana Hong
Correspondent
Wenzhou Wuzhou Import & Export Co., Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/27/2013
Decision Date 02/25/2014
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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