The following data is part of a premarket notification filed by Micron Medical Corporation with the FDA for Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit.
| Device ID | K200848 |
| 510k Number | K200848 |
| Device Name: | Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit |
| Classification | Stimulator, Peripheral Nerve, Implanted (pain Relief) |
| Applicant | Micron Medical Corporation 606 Banyan Trail Boca Raton, FL 33431 |
| Contact | Elizabeth Greene |
| Correspondent | Elizabeth Greene Micron Medical Corporation 606 Banyan Trail Boca Raton, FL 33431 |
| Product Code | GZF |
| CFR Regulation Number | 882.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-31 |
| Decision Date | 2020-08-14 |