GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT


Device Classification Name

pump, infusion

510(k) Number K023062
Device Name GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT
Original Applicant
ABBOTT LABORATORIES INC
200 abbott park rd.
dept 0389 bldg j-45
abbott park, 
IL 
60064 -6133

Original Contact frank pokrop
Regulation Number 880.5725
Classification Product Code
FRN  
Date Received 09/16/2002
Decision Date 09/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls