The following data is part of a premarket notification filed by Cal Huech, Inc. with the FDA for Toothbrush Wash.
Device ID | K994144 |
510k Number | K994144 |
Device Name: | TOOTHBRUSH WASH |
Classification | Toothbrush, Manual |
Applicant | CAL HUECH, INC. 105 SETTLERS TRAIL Warner Robins, GA 31088 |
Contact | Cheryl A Little |
Correspondent | Cheryl A Little CAL HUECH, INC. 105 SETTLERS TRAIL Warner Robins, GA 31088 |
Product Code | EFW |
CFR Regulation Number | 872.6855 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-12-07 |
Decision Date | 2000-03-02 |