The following data is part of a premarket notification filed by Wilson-cook Medical, Inc with the FDA for Wilson-cook Achalasia Balloon.
| Device ID | K182895 |
| 510k Number | K182895 |
| Device Name: | Wilson-Cook Achalasia Balloon |
| Classification | Esophageal Dilator Balloon With Or Without Electrode Sensors |
| Applicant | Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem, NC 27105 |
| Contact | Theresa De Prat |
| Correspondent | Theresa De Prat Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem, NC 27105 |
| Product Code | PID |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-15 |
| Decision Date | 2019-01-25 |
| Summary: | summary |