The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Modification To Plum Xl Infusion Pump.
Device ID | K010924 |
510k Number | K010924 |
Device Name: | MODIFICATION TO PLUM XL INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | ABBOTT LABORATORIES DEPT.37K, BUILDING AP30 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -6157 |
Contact | Frank Pokrop |
Correspondent | Frank Pokrop ABBOTT LABORATORIES DEPT.37K, BUILDING AP30 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -6157 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-03-27 |
Decision Date | 2001-04-06 |