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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 K102328
Device Name BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA
Applicant
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
P.O. BOX 237-023
SHANGHAI,  CN 200237
Applicant Contact Diana Hong
Correspondent
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
P.O. BOX 237-023
SHANGHAI,  CN 200237
Correspondent Contact Diana Hong
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/17/2010
Decision Date 05/13/2011
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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