The following data is part of a premarket notification filed by The Proctor & Gamble Company with the FDA for Oral-b Io Test Drive Power Brush Trial Program Kit.
Device ID | K200881 |
510k Number | K200881 |
Device Name: | Oral-B IO Test Drive Power Brush Trial Program Kit |
Classification | Toothbrush, Powered |
Applicant | The Proctor & Gamble Company 1 Proctor & Gamble Plaza Cincinnati, OH 45202 |
Contact | Michael A. Kaminski |
Correspondent | Michael A. Kaminski The Proctor & Gamble Company 8700 Mason Montgomery Road Mason, OH 45040 |
Product Code | JEQ |
CFR Regulation Number | 872.6865 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-04-02 |
Decision Date | 2020-08-27 |