The following data is part of a premarket notification filed by Procter & Gamble with the FDA for Oral-b Sub-brand Manual Toothbrush.
Device ID | K073224 |
510k Number | K073224 |
Device Name: | ORAL-B SUB-BRAND MANUAL TOOTHBRUSH |
Classification | Toothbrush, Manual |
Applicant | PROCTER & GAMBLE 8700 MASON-MONTGOMERY RD. Mason, OH 45040 |
Contact | Michael A Kaminski |
Correspondent | Michael A Kaminski PROCTER & GAMBLE 8700 MASON-MONTGOMERY RD. Mason, OH 45040 |
Product Code | EFW |
CFR Regulation Number | 872.6855 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-15 |
Decision Date | 2008-02-06 |
Summary: | summary |