ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384


Device Classification Name

pump, infusion, pca

510(k) Number K022203
Device Name ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
Original Applicant
ABBOTT LABORATORIES
dept 0389 bldg j-45
200 abbott park road
abbott park, 
IL 
60064 -6133

Original Contact frank pokrop
Regulation Number 880.5725
Classification Product Code
MEA  
Date Received 07/05/2002
Decision Date 08/01/2002
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