The following data is part of a premarket notification filed by Electro Medical Systems Sa with the FDA for Ems Swiss Orthoclast Chisels For Non-cemented Prosthesis Removal.
| Device ID | K002484 |
| 510k Number | K002484 |
| Device Name: | EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL |
| Classification | Instrument, Surgical, Sonic And Accessory/attachment |
| 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 | JDX |
| Subsequent Product Code | GET |
| Subsequent Product Code | HSX |
| Subsequent Product Code | LZV |
| CFR Regulation Number | 888.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-14 |
| Decision Date | 2000-10-04 |