The following data is part of a premarket notification filed by Neometrics, Inc. with the FDA for Neo Ercp Guidewire.
| Device ID | K123439 |
| 510k Number | K123439 |
| Device Name: | NEO ERCP GUIDEWIRE |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | NEOMETRICS, INC. 2605 FERNBROOK LANE N. SUITE J Plymouth, MN 55447 |
| Contact | Gene Champeau |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-11-08 |
| Decision Date | 2013-01-03 |
| Summary: | summary |