The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Ambulatory Infusion Pump, Model As30c.
| Device ID | K863864 |
| 510k Number | K863864 |
| Device Name: | AMBULATORY INFUSION PUMP, MODEL AS30C |
| Classification | Pump, Infusion |
| Applicant | TRAVENOL LABORATORIES, S.A. LONDONDERRY TURNPIKE Hooksett, NH 03104 |
| Contact | Roger A Leroux |
| Correspondent | Roger A Leroux TRAVENOL LABORATORIES, S.A. LONDONDERRY TURNPIKE Hooksett, NH 03104 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-03 |
| Decision Date | 1987-02-04 |