The following data is part of a premarket notification filed by Braun Gmbh with the FDA for Oral B Professionalcare Series, Oral B Advancepower Series.
Device ID | K061199 |
510k Number | K061199 |
Device Name: | ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES |
Classification | Toothbrush, Powered |
Applicant | BRAUN GMBH 800 BOYLSTON ST PRUDENTIAL TOWER BLDG FL 46 Boston, MA 02199 -8004 |
Contact | Amanda Heffernan |
Correspondent | Amanda Heffernan BRAUN GMBH 800 BOYLSTON ST PRUDENTIAL TOWER BLDG FL 46 Boston, MA 02199 -8004 |
Product Code | JEQ |
CFR Regulation Number | 872.6865 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-04-28 |
Decision Date | 2006-05-31 |
Summary: | summary |