COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET


Device Classification Name

set, administration, intravascular

510(k) Number K991985
Device Name COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET
Applicant
COOK, INC.
p.o. box 489
bloomington, 
IN 
47402

Applicant Contact april lavender
Correspondent
COOK, INC.
p.o. box 489
bloomington, 
IN 
47402

Correspodent Contact april lavender
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 06/14/1999
Decision Date 08/20/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No