I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411


information about

Device Classification Name

set, administration, intravascular

510(k) Number K001872
Device Name I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411
Original Applicant
CODAN US CORP.
15412 verdun circle
irvine, 
CA 
92604

Original Contact richard a basler
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 06/20/2000
Decision Date 09/07/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No