The following data is part of a premarket notification filed by Abbott Mfg., Inc. with the FDA for Abbott Lifecare Standard Tubing Infusion Pump.
Device ID | K965230 |
510k Number | K965230 |
Device Name: | ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | ABBOTT MFG., INC. ONE ABBOTT PARK Abbott Park, IL 60064 |
Contact | David Guzek |
Correspondent | David Guzek ABBOTT MFG., INC. ONE ABBOTT PARK Abbott Park, IL 60064 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-31 |
Decision Date | 1997-07-03 |