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FDA 510(k) Application Details - K151341
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K151341
Device Name
Needle, Hypodermic, Single Lumen
Applicant
NORFOLK MEDICAL
7350 N. RIDGEWAY AVENUE
SKOKIE, IL 60076 US
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Contact
NATAN PHEIL
Other 510(k) Applications for this Contact
Regulation Number
880.5570
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Classification Product Code
FMI
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More FDA Info for this Product Code
Date Received
05/19/2015
Decision Date
08/20/2015
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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