The following data is part of a premarket notification filed by Nico Corporation with the FDA for Nico Myriad Novus.
| Device ID | K191599 |
| 510k Number | K191599 |
| Device Name: | NICO Myriad NOVUS |
| 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 |
| Subsequent Product Code | ERL |
| Subsequent Product Code | FST |
| Subsequent Product Code | HBC |
| Subsequent Product Code | HBI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-17 |
| Decision Date | 2019-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816744027131 | K191599 | 000 |
| 00816744020118 | K191599 | 000 |
| 00816744021139 | K191599 | 000 |
| 00816744021313 | K191599 | 000 |
| 00816744021337 | K191599 | 000 |
| 00816744020095 | K191599 | 000 |
| 00816744020101 | K191599 | 000 |
| 00816744027728 | K191599 | 000 |
| 00816744027476 | K191599 | 000 |
| 00816744027704 | K191599 | 000 |
| 00816744027643 | K191599 | 000 |
| 00816744026813 | K191599 | 000 |
| 00816744021009 | K191599 | 000 |
| 00816744021016 | K191599 | 000 |
| 00816744027124 | K191599 | 000 |
| 00816744027230 | K191599 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NICO MYRIAD NOVUS 88292951 not registered Live/Pending |
Nico Corporation 2019-02-07 |