The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for The Travenol 5 Ml/hr Infusor.
| Device ID | K853881 |
| 510k Number | K853881 |
| Device Name: | THE TRAVENOL 5 ML/HR INFUSOR |
| Classification | Pump, Infusion |
| Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Contact | Patricia S Barsanti |
| Correspondent | Patricia S Barsanti TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-19 |
| Decision Date | 1985-12-02 |