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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name saline, vascular access flush
510(k) Number K113555
Device Name AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
Applicant
AM USA
5209 LINDBAR DRIVE
SUITE 630
NASHVILLE,  TN  37167
Applicant Contact KAREN THOMISON
Correspondent
AM USA
5209 LINDBAR DRIVE
SUITE 630
NASHVILLE,  TN  37167
Correspondent Contact KAREN THOMISON
Regulation Number880.5200
Classification Product Code
NGT  
Date Received12/01/2011
Decision Date 01/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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