The following data is part of a premarket notification filed by Ems Electro Medical Systems Sa with the FDA for Ems Minimaster Led.
| Device ID | K093723 |
| 510k Number | K093723 |
| Device Name: | EMS MINIMASTER LED |
| Classification | Scaler, Ultrasonic |
| Applicant | EMS ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J.m. Nolte |
| Correspondent | Cynthia J.m. Nolte EMS ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-03 |
| Decision Date | 2010-09-08 |
| Summary: | summary |