The following data is part of a premarket notification filed by Neometrics, Inc. with the FDA for Novagold High Performance Guidewire.
Device ID | K150225 |
510k Number | K150225 |
Device Name: | NovaGold High Performance Guidewire |
Classification | Endoscopic Guidewire, Gastroenterology-urology |
Applicant | NEOMETRICS, INC. 2605 FERNBROOK LANE N. SUITE J Plymouth, MN 55447 |
Contact | Dave Liebl |
Correspondent | Dave 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 | 2015-02-02 |
Decision Date | 2015-03-16 |
Summary: | summary |