The following data is part of a premarket notification filed by Electro Medical Systems Sa with the FDA for Swiss Lithoclast Multipurpose Probe.
| Device ID | K992251 |
| 510k Number | K992251 |
| Device Name: | SWISS LITHOCLAST MULTIPURPOSE PROBE |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Sheila Hemeon-heyer |
| Correspondent | Sheila Hemeon-heyer ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-06 |
| Decision Date | 1999-07-27 |
| Summary: | summary |