The following data is part of a premarket notification filed by Koros Usa, Inc. with the FDA for Dilator Tube Set.
| Device ID | K120590 |
| 510k Number | K120590 |
| Device Name: | DILATOR TUBE SET |
| Classification | Neurosurgical Nerve Locator |
| Applicant | KOROS USA, INC. 610 FLINN AVE. Moorpark, CA 93021 |
| Contact | Gabriel Koros |
| Correspondent | Gabriel Koros KOROS USA, INC. 610 FLINN AVE. Moorpark, CA 93021 |
| Product Code | PDQ |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-28 |
| Decision Date | 2013-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840199500076 | K120590 | 000 |
| 10840199500069 | K120590 | 000 |
| 10840199500052 | K120590 | 000 |
| 10840199500045 | K120590 | 000 |
| 10840199500038 | K120590 | 000 |
| 10840199500021 | K120590 | 000 |
| 10840199500014 | K120590 | 000 |