The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Coaxial Balloon Urethral Dilator.
| Device ID | K833690 |
| 510k Number | K833690 |
| Device Name: | COAXIAL BALLOON URETHRAL DILATOR |
| Classification | Replacer, Urethral |
| Applicant | AMERICAN EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FAA |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-18 |
| Decision Date | 1983-11-29 |