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FDA 510(k) Application Details - K111034
Device Classification Name
Saline, Vascular Access Flush
More FDA Info for this Device
510(K) Number
K111034
Device Name
Saline, Vascular Access Flush
Applicant
AM USA
5209 LINDBAR DRIVE
SUITE 640
NASHVILLE, TN 37167 US
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Contact
KAREN THOMISON
Other 510(k) Applications for this Contact
Regulation Number
880.5200
More FDA Info for this Regulation Number
Classification Product Code
NGT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/13/2011
Decision Date
07/14/2011
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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