The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Life Care 1000ml.emp. Cont. W/at. Y-tran.
| Device ID | K791774 |
| 510k Number | K791774 |
| Device Name: | LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRAN |
| Classification | Container, I.v. |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-10 |
| Decision Date | 1979-10-26 |