The following data is part of a premarket notification filed by Cook Endoscopy with the FDA for Hercules 3 Stage Wire Guided Dilation Balloon.
| Device ID | K090183 |
| 510k Number | K090183 |
| Device Name: | HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON |
| Classification | Dilator, Esophageal |
| Applicant | COOK ENDOSCOPY 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Contact | Tiffanny Thomas |
| Correspondent | Tiffanny Thomas COOK ENDOSCOPY 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-26 |
| Decision Date | 2009-09-25 |
| Summary: | summary |