The following data is part of a premarket notification filed by U.s. Dentek Corp. with the FDA for Electric Tooth-brush.
Device ID | K931360 |
510k Number | K931360 |
Device Name: | ELECTRIC TOOTH-BRUSH |
Classification | Toothbrush, Powered |
Applicant | U.S. DENTEK CORP. 32 LEVERONI CT. #101 Novato, CA 94949 |
Contact | John Jansheski |
Correspondent | John Jansheski U.S. DENTEK CORP. 32 LEVERONI CT. #101 Novato, CA 94949 |
Product Code | JEQ |
CFR Regulation Number | 872.6865 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-17 |
Decision Date | 1993-07-13 |