The following data is part of a premarket notification filed by Neometrics, Inc. with the FDA for Novagold High Performance Guidewire.
| Device ID | K133076 |
| 510k Number | K133076 |
| Device Name: | NOVAGOLD HIGH PERFORMANCE GUIDEWIRE |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | NEOMETRICS, INC. 2605 FERNBROOK LANE N. SUITE J Plymouth, MN 55447 |
| Contact | David Liebl |
| Correspondent | David Liebl NEOMETRICS, INC. 2605 FERNBROOK LANE N. SUITE J Plymouth, MN 55447 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-02-20 |
| Summary: | summary |