The following data is part of a premarket notification filed by Advanced Bio Systems, Inc. with the FDA for Mini-pump U-100.
| Device ID | K840616 |
| 510k Number | K840616 |
| Device Name: | MINI-PUMP U-100 |
| Classification | Pump, Infusion |
| Applicant | ADVANCED BIO SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-13 |
| Decision Date | 1984-03-30 |