NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS


Device Classification Name

set, administration, intravascular

510(k) Number K021080
Device Name NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS
Original Applicant
CARDIOMED SUPPLIES, INC.
5 gormley industrial avenue
gormley, ontario, 

CA

l0h 1g0

Original Contact donna mccomb
Regulation Number 880.5440
Classification Product Code
FPA  
Subsequent Product Code
LJT  
Date Received 04/03/2002
Decision Date 08/29/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No