The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Lifeshield Latex-free Primary Iv Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, With 2 Pressure.
| Device ID | K033576 |
| 510k Number | K033576 |
| Device Name: | LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE |
| Classification | Set, Administration, Intravascular |
| Applicant | ABBOTT LABORATORIES DEPT. 389, BLDG. J45-2N 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -6133 |
| Contact | Patricia Melerski |
| Correspondent | Patricia Melerski ABBOTT LABORATORIES DEPT. 389, BLDG. J45-2N 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -6133 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-13 |
| Decision Date | 2003-12-04 |
| Summary: | summary |