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FDA 510(k) Application Details - K120836
Device Classification Name
Saline, Vascular Access Flush
More FDA Info for this Device
510(K) Number
K120836
Device Name
Saline, Vascular Access Flush
Applicant
AMUSA
5209 Linbar Dr Ste 640
NASHVILLE, TN 37211 US
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Contact
KAREN THOMISON
Other 510(k) Applications for this Contact
Regulation Number
880.5200
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Classification Product Code
NGT
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More FDA Info for this Product Code
Date Received
03/20/2012
Decision Date
07/12/2012
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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