The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Lifeshield Extension Set.
| Device ID | K912103 |
| 510k Number | K912103 |
| Device Name: | LIFESHIELD EXTENSION SET |
| Classification | Tubing, Fluid Delivery |
| 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 | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-13 |
| Decision Date | 1991-12-13 |