The following data is part of a premarket notification filed by Nico Corporation with the FDA for Nico Brainpath & Accessories, Nico Brainpath, Nico Shepherd's Hook.
| Device ID | K150378 |
| 510k Number | K150378 |
| Device Name: | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | NICO Corporation 250 E 96TH ST Suite 125 Indianapolis, IN 46240 |
| Contact | Sean Spence |
| Correspondent | Sean Spence NICO Corporation 250 E 96TH ST Suite 125 Indianapolis, IN 46240 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-13 |
| Decision Date | 2015-06-12 |
| Summary: | summary |