The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Wilson Cook Wire Guide And Protective Guide.
| Device ID | K910497 |
| 510k Number | K910497 |
| Device Name: | WILSON COOK WIRE GUIDE AND PROTECTIVE GUIDE |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
| Contact | Richard F Marshall |
| Correspondent | Richard F Marshall WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-05 |
| Decision Date | 1991-04-02 |