The following data is part of a premarket notification filed by Nico Corporation with the FDA for Nico Triowand.
| Device ID | K162075 |
| 510k Number | K162075 |
| Device Name: | NICO TRIOwand |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NICO Corporation 250 East 96th Street, Suite 125 Indianapolis, IN 46240 |
| Contact | Sean Spence |
| Correspondent | Sean Spence NICO Corporation 250 East 96th Street, Suite 125 Indianapolis, IN 46240 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-27 |
| Decision Date | 2016-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816744028289 | K162075 | 000 |