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FDA 510(k) Application Details - K173803
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K173803
Device Name
Needle, Hypodermic, Single Lumen
Applicant
B. Braun Medical Inc.
901 Marcon Blvd.
Allentown, PA 18109 US
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Contact
Kimberly Smith
Other 510(k) Applications for this Contact
Regulation Number
880.5570
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Classification Product Code
FMI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/15/2017
Decision Date
06/11/2018
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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