The following data is part of a premarket notification filed by Perio Protect Llc with the FDA for Perio Protect Tray.
| Device ID | K031809 |
| 510k Number | K031809 |
| Device Name: | PERIO PROTECT TRAY |
| Classification | Tray, Fluoride, Disposable |
| Applicant | PERIO PROTECT LLC 1625 MASSACHUSETTS AVENUE NW; SUITE 300 Washington, DC 20036 -2247 |
| Contact | David L Rosen |
| Correspondent | David L Rosen PERIO PROTECT LLC 1625 MASSACHUSETTS AVENUE NW; SUITE 300 Washington, DC 20036 -2247 |
| Product Code | KMT |
| CFR Regulation Number | 872.6870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-12 |
| Decision Date | 2004-01-23 |
| Summary: | summary |