The following data is part of a premarket notification filed by Abbott Mfg., Inc. with the FDA for Lifeshield Primary I.v. Set With Backcheck Valve.
| Device ID | K971293 |
| 510k Number | K971293 |
| Device Name: | LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE |
| Classification | Set, Administration, Intravascular |
| Applicant | ABBOTT MFG., INC. TWO HUNDRED S. ABBOTT PRK. RD. D 389, BLDG AP 30 Abbott Park, IL 60064 -3500 |
| Contact | Thomas P Sampogna |
| Correspondent | Thomas P Sampogna ABBOTT MFG., INC. TWO HUNDRED S. ABBOTT PRK. RD. D 389, BLDG AP 30 Abbott Park, IL 60064 -3500 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-07 |
| Decision Date | 1997-06-27 |