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FDA 510(k) Application Details - K140568
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K140568
Device Name
Needle, Hypodermic, Single Lumen
Applicant
FACET TECHNOLOGIES, LLC
112 TOWN PARK DR.
SUITE 300
KENNESAW, GA 30144 US
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Contact
JENNIFER REGISTER
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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
03/05/2014
Decision Date
05/13/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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