AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE


Device Classification Name

saline, vascular access flush

510(k) Number K111034
Device Name AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
Applicant
AM USA
5209 lindbar drive
suite 640
nashville, 
TN 
37167

Applicant Contact karen thomison
Correspondent
AM USA
5209 lindbar drive
suite 640
nashville, 
TN 
37167

Correspodent Contact karen thomison
Regulation Number 880.5200
Classification Product Code
NGT  
Date Received 04/13/2011
Decision Date 07/14/2011
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