The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Lifeshield Primary Iv Set Conv. Pin. Clave; Lf Lc 5000 Plumset-dual W/conv Pin & Cap Port; Lifeshield Lf Macrobore Ext..
| Device ID | K030002 |
| 510k Number | K030002 |
| Device Name: | LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT. |
| Classification | Set, Administration, Intravascular |
| Applicant | ABBOTT LABORATORIES D-389, BLDG. J45-2 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -6157 |
| Contact | Nocohl R Wilding |
| Correspondent | Nocohl R Wilding ABBOTT LABORATORIES D-389, BLDG. J45-2 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -6157 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-02 |
| Decision Date | 2003-01-27 |