The following data is part of a premarket notification filed by Thomas M. Foti, M.d. with the FDA for Version Of A Closed-flow Sys. Caloric.
| Device ID | K813490 |
| 510k Number | K813490 |
| Device Name: | VERSION OF A CLOSED-FLOW SYS. CALORIC |
| Classification | Unit, Examining/treatment, Ent |
| Applicant | THOMAS M. FOTI, M.D. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ETF |
| CFR Regulation Number | 874.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-04 |
| Decision Date | 1982-01-07 |