The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Esophageal Z-stent With Dua Anti-reflux Valve.
| Device ID | K011591 |
| 510k Number | K011591 |
| Device Name: | ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE |
| Classification | Prosthesis, Esophageal |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Contact | Paula Joyce |
| Correspondent | Paula Joyce WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Product Code | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-24 |
| Decision Date | 2002-07-19 |
| Summary: | summary |