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FDA 510(k) Application Details - K133058
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K133058
Device Name
Needle, Hypodermic, Single Lumen
Applicant
WENZHOU WUZHOU IMPORT & EXPORT CO., LTD
P.O. BOX 120-119
SHANGHAI 200120 CN
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Contact
Diana Hong
Other 510(k) Applications for this Contact
Regulation Number
880.5570
More FDA Info for this Regulation Number
Classification Product Code
FMI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/27/2013
Decision Date
02/25/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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