The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Xl3m Infusion Pump.
Device ID | K952799 |
510k Number | K952799 |
Device Name: | ABBOTT XL3M INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. D389, AP30 Abbott Park, IL 60064 |
Contact | David T Guzek |
Correspondent | David T Guzek ABBOTT LABORATORIES ONE ABBOTT PARK RD. D389, AP30 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 | 1995-06-19 |
Decision Date | 1996-01-18 |