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 |
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 |
00816744020095 | K191599 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NICO MYRIAD NOVUS 88292951 not registered Live/Pending |
Nico Corporation 2019-02-07 |