BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR


Device Classification Name

set, blood transfusion

510(k) Number K073339
Device Name BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR
Applicant
FENWAL, INC.
three corporate drive
lake zurich, 
IL 
60047

Applicant Contact tammy davis
Correspondent
FENWAL, INC.
three corporate drive
lake zurich, 
IL 
60047

Correspodent Contact tammy davis
Regulation Number 880.5440
Classification Product Code
BRZ  
Date Received 11/28/2007
Decision Date 03/03/2008
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