SYMBIQ INFUSION AND ADMINSTRATION SET


Device Classification Name

pump, infusion

510(k) Number K110901
Device Name SYMBIQ INFUSION AND ADMINSTRATION SET
Applicant
HOSPIRA, INC.
275 north field dr.
lake forest, 
IL 
60045

Applicant Contact ray silkaitis
Correspondent
HOSPIRA, INC.
275 north field dr.
lake forest, 
IL 
60045

Correspodent Contact ray silkaitis
Regulation Number 880.5725
Classification Product Code
FRN  
Subsequent Product Code
FPA  
Date Received 03/31/2011
Decision Date 03/05/2012
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