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FDA 510(k) Application Details - K173279
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K173279
Device Name
Needle, Hypodermic, Single Lumen
Applicant
MYCO Medical Supplies, Inc.
2015 Production Drive
Apex, NC 27539 US
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Contact
Sanjiv Kumar
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
10/13/2017
Decision Date
05/14/2018
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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