The following data is part of a premarket notification filed by Med-sonics Corp with the FDA for Uretron Model Urt.
| Device ID | K111058 |
| 510k Number | K111058 |
| Device Name: | URETRON MODEL URT |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | MED-SONICS CORP 5451 MERWIN LANE, SUITE 203 Erie, PA 16510 |
| Contact | William A Stoll |
| Correspondent | William A Stoll MED-SONICS CORP 5451 MERWIN LANE, SUITE 203 Erie, PA 16510 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-18 |
| Decision Date | 2012-03-30 |
| Summary: | summary |