The following data is part of a premarket notification filed by Fairleigh Dickinson Laboratories, Inc. with the FDA for Fdl, Inc.'s Transport System.
| Device ID | K895187 |
| 510k Number | K895187 |
| Device Name: | FDL, INC.'S TRANSPORT SYSTEM |
| Classification | System, Transport, Aerobic |
| Applicant | FAIRLEIGH DICKINSON LABORATORIES, INC. 1249 AMBLER AVE. Abilene, TX 79601 |
| Contact | Patricia Mansfield |
| Correspondent | Patricia Mansfield FAIRLEIGH DICKINSON LABORATORIES, INC. 1249 AMBLER AVE. Abilene, TX 79601 |
| Product Code | JTW |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-11 |
| Decision Date | 1989-10-24 |