The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Lifecare Pca 3 Infuser, Model 12384.
| Device ID | K022203 |
| 510k Number | K022203 |
| Device Name: | ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 |
| Classification | Pump, Infusion, Pca |
| Applicant | ABBOTT LABORATORIES DEPT 0389 BLDG J-45 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -6133 |
| Contact | Frank Pokrop |
| Correspondent | Frank Pokrop ABBOTT LABORATORIES DEPT 0389 BLDG J-45 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -6133 |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-05 |
| Decision Date | 2002-08-01 |
| Summary: | summary |