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FDA 510(k) Application Details - K173757
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K173757
Device Name
Needle, Hypodermic, Single Lumen
Applicant
Greiner Bio-One NA Inc
4238 Capital Drive
Monroe, NC 28110 US
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Contact
Manfred Abel
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
12/11/2017
Decision Date
04/19/2018
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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