The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Plum A+infusion Pump, Model 11971.
Device ID | K011442 |
510k Number | K011442 |
Device Name: | ABBOTT PLUM A+INFUSION PUMP, MODEL 11971 |
Classification | Pump, Infusion |
Applicant | ABBOTT LABORATORIES DEPT 37K BLDG AP30 200 ABBOTT PARK ROAD Abbott Park, IL 60064 |
Contact | Frank Pokrop |
Correspondent | Frank Pokrop ABBOTT LABORATORIES DEPT 37K BLDG AP30 200 ABBOTT PARK ROAD Abbott Park, IL 60064 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-05-10 |
Decision Date | 2001-06-05 |