INFUSION SETS


Device Classification Name

set, administration, intravascular

510(k) Number K103344
Device Name INFUSION SETS
Applicant
HOSPIRA, INC.
275 north field dr.
lake forest, 
IL 
60045

Applicant Contact rebecca andersen
Correspondent
HOSPIRA, INC.
275 north field dr.
lake forest, 
IL 
60045

Correspodent Contact rebecca andersen
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 11/15/2010
Decision Date 12/10/2010
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