The following data is part of a premarket notification filed by Amdev, Inc. with the FDA for Lytening Tm 6/r.
| Device ID | K904726 |
| 510k Number | K904726 |
| Device Name: | LYTENING TM 6/R |
| Classification | Electrode, Ion Specific, Calcium |
| Applicant | AMDEV, INC. 35 CHERRY HILL DR. Danvers, MA 01923 -2565 |
| Contact | Connie J Hertel |
| Correspondent | Connie J Hertel AMDEV, INC. 35 CHERRY HILL DR. Danvers, MA 01923 -2565 |
| Product Code | JFP |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-17 |
| Decision Date | 1990-12-18 |