The following data is part of a premarket notification filed by Abbott Mfg., Inc. with the FDA for Lifeshield Extension Set.
| Device ID | K941214 |
| 510k Number | K941214 |
| Device Name: | LIFESHIELD EXTENSION SET |
| Classification | Tubing, Fluid Delivery |
| Applicant | ABBOTT MFG., INC. ONE ABBOTT PARK Abbott Park, IL 60064 |
| Contact | Frederick A Gustafson |
| Correspondent | Frederick A Gustafson ABBOTT MFG., INC. ONE ABBOTT PARK Abbott Park, IL 60064 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-10 |
| Decision Date | 1994-10-03 |