The following data is part of a premarket notification filed by Cook Endoscopy with the FDA for Cook Endoscopy Esophageal Dilation Balloon.
| Device ID | K061937 |
| 510k Number | K061937 |
| Device Name: | COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON |
| Classification | Dilator, Esophageal |
| Applicant | COOK ENDOSCOPY 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Contact | Mabel L Hunter |
| Correspondent | Mabel L Hunter COOK ENDOSCOPY 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-10 |
| Decision Date | 2006-12-01 |
| Summary: | summary |