The following data is part of a premarket notification filed by (ems Sa) Electro Medical Systems with the FDA for Ems Swiss Orthoclast.
| Device ID | K991588 |
| 510k Number | K991588 |
| Device Name: | EMS SWISS ORTHOCLAST |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | (EMS SA) ELECTRO MEDICAL SYSTEMS 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Sheila Hameon-heyer |
| Correspondent | Sheila Hameon-heyer (EMS SA) ELECTRO MEDICAL SYSTEMS 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | HSZ |
| Subsequent Product Code | GET |
| Subsequent Product Code | LZV |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-07 |
| Decision Date | 1999-07-21 |
| Summary: | summary |