The following data is part of a premarket notification filed by Myotronics-noromed, Inc. with the FDA for Myo-trode Sg Disposable Electrode.
| Device ID | K040400 |
| 510k Number | K040400 |
| Device Name: | MYO-TRODE SG DISPOSABLE ELECTRODE |
| Classification | Stimulator, Muscle, Powered, Dental |
| Applicant | MYOTRONICS-NOROMED, INC. 15425 53RD AVE. SOUTH Tukwila, WA 98188 |
| Contact | Fray Adib |
| Correspondent | Fray Adib MYOTRONICS-NOROMED, INC. 15425 53RD AVE. SOUTH Tukwila, WA 98188 |
| Product Code | NUW |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D79243003 | K040400 | 000 |
| D79240702 | K040400 | 000 |
| D79240602 | K040400 | 000 |