The following data is part of a premarket notification filed by Philips Oral Healthcare, Inc. with the FDA for Sonicare Advance Toothbrush, Model 4900.
Device ID | K040416 |
510k Number | K040416 |
Device Name: | SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 |
Classification | Toothbrush, Powered |
Applicant | PHILIPS ORAL HEALTHCARE, INC. 35301 S.E. CENTER ST. Snoqualmie, WA 98065 |
Contact | Rose Degiacomo |
Correspondent | Rose Degiacomo PHILIPS ORAL HEALTHCARE, INC. 35301 S.E. CENTER ST. Snoqualmie, WA 98065 |
Product Code | JEQ |
CFR Regulation Number | 872.6865 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-02-18 |
Decision Date | 2004-07-02 |
Summary: | summary |