The following data is part of a premarket notification filed by Nico Corporation with the FDA for Nico Triowand.
| Device ID | K150993 |
| 510k Number | K150993 |
| Device Name: | NICO TRIOwand |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NICO CORPORATION 250 E. 96 TH ST., SUITE 125 Indianapolis, IN 46240 |
| Contact | Jay Dittman |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-04-15 |
| Decision Date | 2015-04-23 |
| Summary: | summary |