IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)


Device Classification Name

set, i.v. fluid transfer

510(k) Number K960466
Device Name IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)
Applicant
ABBOTT LABORATORIES
200 abbott park rd.
d-389, bldg ap30
abbott park, 
IL 
60064 -3500

Applicant Contact jill n sackett
Correspondent
ABBOTT LABORATORIES
200 abbott park rd.
d-389, bldg ap30
abbott park, 
IL 
60064 -3500

Correspodent Contact jill n sackett
Regulation Number 880.5440
Classification Product Code
LHI  
Date Received 01/02/1996
Decision Date 05/29/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No