SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE


Device Classification Name

saline, vascular access flush

510(k) Number K103740
Device Name SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
Applicant
SPECTRA MEDICAL DEVICES, INC.
3000 k st., nw
washington, 
DC 
20007

Applicant Contact david l rosen, b.s. pharm., j.d.
Correspondent
SPECTRA MEDICAL DEVICES, INC.
3000 k st., nw
washington, 
DC 
20007

Correspodent Contact david l rosen, b.s. pharm., j.d.
Regulation Number 880.5200
Classification Product Code
NGT  
Date Received 12/22/2010
Decision Date 07/29/2011
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