The following data is part of a premarket notification filed by Ems Electro Medical Systems Sa with the FDA for Ems Piezon Master 700.
Device ID | K093000 |
510k Number | K093000 |
Device Name: | EMS PIEZON MASTER 700 |
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 | 2009-09-28 |
Decision Date | 2010-07-30 |