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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 K120836
Device Name 0.9% SODIUM CHLORIDE FLISH SYRINGE
Applicant
Am USA
5209 Linbar Dr., Suite 640
Nashville,  TN  37211
Applicant Contact KAREN THOMISON
Correspondent
Am USA
5209 Linbar Dr., Suite 640
Nashville,  TN  37211
Correspondent Contact KAREN THOMISON
Regulation Number880.5200
Classification Product Code
NGT  
Date Received03/20/2012
Decision Date 07/12/2012
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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