The following data is part of a premarket notification filed by E.m.s. Electro Medical Systems S.a. with the FDA for Ems Piezon Master Surgery.
| Device ID | K072146 |
| 510k Number | K072146 |
| Device Name: | EMS PIEZON MASTER SURGERY |
| Classification | Drill, Bone, Powered |
| Applicant | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 49 PLAIN ST North Attleboro, MA 02760 |
| Contact | Susan Bonapace |
| Correspondent | Susan Bonapace E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 49 PLAIN ST North Attleboro, MA 02760 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-03 |
| Decision Date | 2007-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353087524 | K072146 | 000 |
| 07613353002688 | K072146 | 000 |
| 07613353002671 | K072146 | 000 |
| 07613353002664 | K072146 | 000 |
| 07613353002657 | K072146 | 000 |
| 07613353002640 | K072146 | 000 |
| 07613353002633 | K072146 | 000 |
| 07613353002626 | K072146 | 000 |
| 07613353001803 | K072146 | 000 |
| 07613353175269 | K072146 | 000 |
| 07613353196318 | K072146 | 000 |
| 07613353029777 | K072146 | 000 |
| 07613353029784 | K072146 | 000 |
| 07613353087487 | K072146 | 000 |
| 07613353030025 | K072146 | 000 |
| 07613353030001 | K072146 | 000 |
| 07613353029982 | K072146 | 000 |
| 07613353029968 | K072146 | 000 |
| 07613353029845 | K072146 | 000 |
| 07613353029821 | K072146 | 000 |
| 07613353029814 | K072146 | 000 |
| 07613353029807 | K072146 | 000 |
| 07613353029791 | K072146 | 000 |
| 07613353048754 | K072146 | 000 |