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FDA 510(k) Application Details - K171144
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K171144
Device Name
Needle, Hypodermic, Single Lumen
Applicant
Medbio LLC.
4846 Citrus Way
Cooper City, FL 33330 US
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Contact
Jatin Rajani
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
04/19/2017
Decision Date
09/12/2017
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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