The following data is part of a premarket notification filed by Surgentec, Llc with the FDA for Alara Neuro Access Kit.
| Device ID | K190163 |
| 510k Number | K190163 |
| Device Name: | ALARA Neuro Access Kit |
| Classification | Neurosurgical Nerve Locator |
| Applicant | SurGenTec, LLC 7601 N Federal Highway #150A Boca Raton, FL 33487 |
| Contact | Travis Greenhalgh |
| Correspondent | Stephen Inglese Quality Solutions And Support, LLC PO Box 8271 Holland, MI 49422 |
| Product Code | PDQ |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-31 |
| Decision Date | 2019-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858406007396 | K190163 | 000 |
| 00858406007297 | K190163 | 000 |
| 00858406007303 | K190163 | 000 |
| 00858406007310 | K190163 | 000 |
| 00858406007327 | K190163 | 000 |
| 00858406007334 | K190163 | 000 |
| 00858406007341 | K190163 | 000 |
| 00858406007365 | K190163 | 000 |
| 00858406007372 | K190163 | 000 |
| 00858406007419 | K190163 | 000 |
| 00858406007389 | K190163 | 000 |
| 00858406007129 | K190163 | 000 |