The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Sentio Mmg Gen 2.
| Device ID | K173526 |
| 510k Number | K173526 |
| Device Name: | SENTIO MMG Gen 2 |
| Classification | Neurosurgical Nerve Locator |
| Applicant | Medos International, SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Karen Sylvia |
| Correspondent | Anna D'lima DePuy Synthes 325 Paramont Drive Raynham, MA 02767 |
| Product Code | PDQ |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-14 |
| Decision Date | 2018-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705034534753 | K173526 | 000 |
| 20705034534746 | K173526 | 000 |
| 20705034534739 | K173526 | 000 |
| 10705034534763 | K173526 | 000 |