The following data is part of a premarket notification filed by E.m.s. Electro Medical Systems S.a. with the FDA for Minimaster Ultrasonic Scaler.
| Device ID | K050710 |
| 510k Number | K050710 |
| Device Name: | MINIMASTER ULTRASONIC SCALER |
| Classification | Scaler, Ultrasonic |
| Applicant | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Cynthia J.m. Nolte |
| Correspondent | Cynthia J.m. Nolte E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-18 |
| Decision Date | 2005-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353168568 | K050710 | 000 |
| 07613353086015 | K050710 | 000 |
| 07613353086008 | K050710 | 000 |
| 07613353085995 | K050710 | 000 |
| 07613353085988 | K050710 | 000 |
| 07613353073251 | K050710 | 000 |
| 07613353073206 | K050710 | 000 |
| 07613353072940 | K050710 | 000 |
| 07613353002886 | K050710 | 000 |
| 07613353002596 | K050710 | 000 |
| 07613353002589 | K050710 | 000 |
| 07613353002572 | K050710 | 000 |
| 07613353001759 | K050710 | 000 |
| 07613353086022 | K050710 | 000 |
| 07613353086039 | K050710 | 000 |
| 07613353141363 | K050710 | 000 |
| 07613353141127 | K050710 | 000 |
| 07613353087432 | K050710 | 000 |
| 07613353087425 | K050710 | 000 |
| 07613353087418 | K050710 | 000 |
| 07613353087401 | K050710 | 000 |
| 07613353086701 | K050710 | 000 |
| 07613353086695 | K050710 | 000 |
| 07613353086688 | K050710 | 000 |
| 07613353086671 | K050710 | 000 |
| 07613353086664 | K050710 | 000 |
| 07613353086657 | K050710 | 000 |
| 07613353192488 | K050710 | 000 |