The following data is part of a premarket notification filed by Procter & Gamble Co. with the FDA for Oral-b Test Drive Power Brush Trial Program Kit, Oral-b Test Drive Power Toothbrush Kit, Oral-b Test Drive Refill Kit.
Device ID | K141018 |
510k Number | K141018 |
Device Name: | ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT |
Classification | Toothbrush, Powered |
Applicant | PROCTER & GAMBLE CO. 8700 MASON-MONTGOMERY RD. Mason, OH 45040 -9462 |
Contact | Michael Kaminski, Ph.d. |
Correspondent | Michael Kaminski, Ph.d. PROCTER & GAMBLE CO. 8700 MASON-MONTGOMERY RD. Mason, OH 45040 -9462 |
Product Code | JEQ |
CFR Regulation Number | 872.6865 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-21 |
Decision Date | 2014-09-15 |
Summary: | summary |