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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 K133685
Device Name 0.9% SODIUM CHLORIDE FLUSH SYRINGE
Applicant
AMUSA
5209 Linbar Dr Ste 640
NASHVILLE,  TN  37211
Applicant Contact ALEX FERRI
Correspondent
AMUSA
5209 Linbar Dr Ste 640
NASHVILLE,  TN  37211
Correspondent Contact ALEX FERRI
Regulation Number880.5200
Classification Product Code
NGT  
Date Received12/02/2013
Decision Date 08/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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