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 |