The following data is part of a premarket notification filed by Electro Medical Systems Sa with the FDA for Ems Swiss Lithoclast Lithotripter.
| Device ID | K963285 |
| 510k Number | K963285 |
| Device Name: | EMS SWISS LITHOCLAST LITHOTRIPTER |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-21 |
| Decision Date | 1997-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353000332 | K963285 | 000 |
| 07613353151843 | K963285 | 000 |
| 07613353064266 | K963285 | 000 |