The following data is part of a premarket notification filed by Azo Enterprises with the FDA for Bacti-stop Toothbrush Cleaner And Sanitizer.
Device ID | K992435 |
510k Number | K992435 |
Device Name: | BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER |
Classification | Toothbrush, Manual |
Applicant | AZO ENTERPRISES 6114 NORTH SACRAMENTO Chicago, IL 60659 |
Contact | Nabil Azo |
Correspondent | Nabil Azo AZO ENTERPRISES 6114 NORTH SACRAMENTO Chicago, IL 60659 |
Product Code | EFW |
CFR Regulation Number | 872.6855 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-22 |
Decision Date | 1999-10-15 |