American Edwards Laboratories · Class III · Cleared Nov 29, 1983
| K-number | K833690 |
| Device name | COAXIAL BALLOON URETHRAL DILATOR |
| Applicant | American Edwards Laboratories |
| Product code | FAA |
| Device class | Class III |
| Decision date | Nov 29, 1983 |
| Decision | Substantially Equivalent |
| Regulation | — |
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