The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Lifecare 175 Infuser, Modification.
| Device ID | K944190 |
| 510k Number | K944190 |
| Device Name: | LIFECARE 175 INFUSER, MODIFICATION |
| Classification | Pump, Infusion |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Frederick A Gustafson |
| Correspondent | Frederick A 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 | 1994-07-18 |
| Decision Date | 1995-05-23 |