Leo Minor
Light, Surgical, Ceiling Mounted
SUNNEX, INC.
The following data is part of a premarket notification filed by Sunnex, Inc. with the FDA for Leo Minor.
Pre-market Notification Details
| Device ID | K142984 |
| 510k Number | K142984 |
| Device Name: | Leo Minor |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | SUNNEX, INC. 9319 FORSYTH PARK DRIVE Charlotte, NC 28273 |
| Contact | Tish Mendick |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-10-16 |
| Decision Date | 2014-10-29 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853538008587 | K142984 | 000 |
| 00853538008570 | K142984 | 000 |
| 00853538008549 | K142984 | 000 |
| 00853538008396 | K142984 | 000 |
| 00853538008389 | K142984 | 000 |
| 00853538008372 | K142984 | 000 |
| 00853538008365 | K142984 | 000 |
| 00853538008624 | K142984 | 000 |
| 00853538008631 | K142984 | 000 |
Trademark Results [Leo Minor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LEO MINOR 85820501 4561019 Live/Registered |
Sunnex 2013-01-10 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.