The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Lifecare 5000 Pump.
Device ID | K911401 |
510k Number | K911401 |
Device Name: | ABBOTT LIFECARE 5000 PUMP |
Classification | Pump, Infusion |
Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
Contact | Frederick Gustafson |
Correspondent | Frederick Gustafson ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-29 |
Decision Date | 1991-05-28 |