The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Plum A+ Infusion Pump With A Hpl/rs Plug-and-play Module.
| Device ID | K031185 |
| 510k Number | K031185 |
| Device Name: | ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE |
| Classification | Pump, Infusion |
| Applicant | ABBOTT LABORATORIES D-389, BLDG. J45-2 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -6157 |
| Contact | Patricia Melerski |
| Correspondent | Neil E Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-04-15 |
| Decision Date | 2003-04-30 |
| Summary: | summary |