IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR


Device Classification Name

set, administration, intravascular

510(k) Number K030385
Device Name IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR
Applicant
KAWASUMI LABORATORIES AMERICA, INC.
5905 c hampton oaks pkwy.
tampa, 
FL 
33610

Applicant Contact jack pavlo
Correspondent
KAWASUMI LABORATORIES AMERICA, INC.
5905 c hampton oaks pkwy.
tampa, 
FL 
33610

Correspodent Contact jack pavlo
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 02/05/2003
Decision Date 04/15/2003
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