The following data is part of a premarket notification filed by Ems Electro Medical Systems Sa with the FDA for Ems Air-flow Handy Perio.
| Device ID | K092289 |
| 510k Number | K092289 |
| Device Name: | EMS AIR-FLOW HANDY PERIO |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | EMS ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J Nolte |
| Correspondent | Cynthia J Nolte EMS ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-29 |
| Decision Date | 2009-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353170189 | K092289 | 000 |
| 07613353170165 | K092289 | 000 |
| 07613353133580 | K092289 | 000 |
| 07613353002374 | K092289 | 000 |
| 07613353170424 | K092289 | 000 |
| 07613353065300 | K092289 | 000 |
| 07613353065287 | K092289 | 000 |