The following data is part of a premarket notification filed by E.m.s. Electro Medical Systems S.a. with the FDA for Perio-flow Nozzle.
| Device ID | K171174 |
| 510k Number | K171174 |
| Device Name: | PERIO-FLOW Nozzle |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | E.M.S. Electro Medical Systems S.A. 31 CH. De La Vuarpilliere Nyon, CH Ch-1260 |
| Contact | Suzanne Fassio-hardy |
| Correspondent | Christina Henza Can-Do-Medical 31 CH. De La Vuarpilliere Nyon, CH Ch-1260 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-21 |
| Decision Date | 2017-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353155223 | K171174 | 000 |
| 07613353174293 | K171174 | 000 |
| 07613353204563 | K171174 | 000 |
| 07613353198305 | K171174 | 000 |
| 07613353195908 | K171174 | 000 |
| 07613353195885 | K171174 | 000 |
| 07613353170172 | K171174 | 000 |