The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Tracer Metro Smart Wire Guide.
| Device ID | K033754 |
| 510k Number | K033754 |
| Device Name: | TRACER METRO SMART WIRE GUIDE |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Contact | Marge Walls-walker |
| Correspondent | Marge Walls-walker WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-01 |
| Decision Date | 2003-12-30 |
| Summary: | summary |