The following data is part of a premarket notification filed by Electro Medical Systems Sa with the FDA for Minipiezon.
| Device ID | K953026 |
| 510k Number | K953026 |
| Device Name: | MINIPIEZON |
| Classification | Scaler, Ultrasonic |
| Applicant | ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Steven Clarke |
| Correspondent | Steven Clarke 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 | 1995-06-29 |
| Decision Date | 1995-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353059941 | K953026 | 000 |
| 07613353191658 | K953026 | 000 |