The following data is part of a premarket notification filed by Elmed Usa with the FDA for Vibrolith And Vibrolith Plus Intracorporeal Lithotriptor.
| Device ID | K092033 |
| 510k Number | K092033 |
| Device Name: | VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | ELMED USA 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Jonathan Ward |
| Correspondent | Jonathan Ward ELMED USA 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2010-04-30 |
| Summary: | summary |