The following data is part of a premarket notification filed by Nico Corporation with the FDA for Brain Port.
| Device ID | K120691 |
| 510k Number | K120691 |
| Device Name: | BRAIN PORT |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | NICO CORPORATION 250 E 96th St Ste 125 Indianapolis, IN 46240 |
| Contact | Jay Dittman |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-03-07 |
| Decision Date | 2012-06-05 |
| Summary: | summary |