The following data is part of a premarket notification filed by Thomas J. Fogarty, M.d. with the FDA for Coaxial Balloon Urethral Dilator.
| Device ID | K831384 |
| 510k Number | K831384 |
| Device Name: | COAXIAL BALLOON URETHRAL DILATOR |
| Classification | Dilator, Urethral, Mechanical |
| Applicant | THOMAS J. FOGARTY, M.D. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FAH |
| CFR Regulation Number | 876.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-28 |
| Decision Date | 1983-07-26 |