0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE


Device Classification Name

saline, vascular access flush

510(k) Number K121050
Device Name 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE
Applicant
BECTON DICKINSON & CO.
1 becton drive
franklin lakes, 
NJ 
07417

Applicant Contact john roberts
Correspondent
BECTON DICKINSON & CO.
1 becton drive
franklin lakes, 
NJ 
07417

Correspodent Contact john roberts
Regulation Number 880.5200
Classification Product Code
NGT  
Date Received 04/06/2012
Decision Date 02/07/2013
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