The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Plum A+ Infusion Pump.
Device ID | K982159 |
510k Number | K982159 |
Device Name: | ABBOTT PLUM A+ INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | ABBOTT LABORATORIES 1401 SHERIDAN RD. North Chicago, IL 60064 -4000 |
Contact | David T Guzek |
Correspondent | David T Guzek ABBOTT LABORATORIES 1401 SHERIDAN RD. North Chicago, IL 60064 -4000 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-06-19 |
Decision Date | 1999-01-12 |