SAFETY INFUSION SET


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K080235
Device Name SAFETY INFUSION SET
Applicant
GREINER BIO-ONE VACUETTE NORTH AMERICA
13801 eck road
hydes, 
MD 
21082

Applicant Contact judith smith
Correspondent
GREINER BIO-ONE VACUETTE NORTH AMERICA
13801 eck road
hydes, 
MD 
21082

Correspodent Contact judith smith
Regulation Number 880.5570
Classification Product Code
FMI  
Date Received 01/30/2008
Decision Date 04/24/2008
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