The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Provider Anne Infuser.
Device ID | K922702 |
510k Number | K922702 |
Device Name: | PROVIDER ANNE INFUSER |
Classification | Pump, Infusion |
Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
Contact | Frederick Gustafson |
Correspondent | Frederick Gustafson ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-05 |
Decision Date | 1994-07-13 |