The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Fx Wire Advanced Measurement Guidewire.
| Device ID | K050304 |
| 510k Number | K050304 |
| Device Name: | FX WIRE ADVANCED MEASUREMENT GUIDEWIRE |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | CONMED CORP. 129 CONCORD ROAD BUILDING 3 Billerica, MA 01821 |
| Contact | Thomas Hirte |
| Correspondent | Thomas Hirte CONMED CORP. 129 CONCORD ROAD BUILDING 3 Billerica, MA 01821 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-08 |
| Decision Date | 2005-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10653405052906 | K050304 | 000 |
| 10653405050568 | K050304 | 000 |
| 10653405050506 | K050304 | 000 |
| 10653405050469 | K050304 | 000 |