The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Flo-gard 2000 Enternal Pump & Travasorb.
| Device ID | K823063 |
| 510k Number | K823063 |
| Device Name: | FLO-GARD 2000 ENTERNAL PUMP & TRAVASORB |
| Classification | Pump, Infusion |
| Applicant | TRAVENOL LABORATORIES, S.A. 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 | 1982-10-18 |
| Decision Date | 1982-11-30 |