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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 K073127
Device Name BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G
Applicant
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
SUITE 8D, NO.19, LANE 999
ZHONGSHAN NO.2 ROAD(S)
SHANGHAI,  CN 200030
Applicant Contact Diana Hong
Correspondent
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
SUITE 8D, NO.19, LANE 999
ZHONGSHAN NO.2 ROAD(S)
SHANGHAI,  CN 200030
Correspondent Contact Diana Hong
Regulation Number880.5570
Classification Product Code
FMI  
Date Received11/06/2007
Decision Date 12/20/2007
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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