Swiss LithoClast Trilogy
Lithotriptor, Electro-hydraulic
EMS Electro Medical Systems SA
The following data is part of a premarket notification filed by Ems Electro Medical Systems Sa with the FDA for Swiss Lithoclast Trilogy.
Pre-market Notification Details
| Device ID | K191124 |
| 510k Number | K191124 |
| Device Name: | Swiss LithoClast Trilogy |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | EMS Electro Medical Systems SA Ch. De La Vuarpilliere 31 Nyon, CH 1260 |
| Contact | Timothee Deblock |
| Correspondent | Sheila Hemeon-heyer Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-29 |
| Decision Date | 2019-05-29 |
Trademark Results [Swiss LithoClast Trilogy]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SWISS LITHOCLAST TRILOGY 79210552 not registered Live/Pending |
EMS Electro Medical Systems GmbH 2017-04-28 |
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