The following data is part of a premarket notification filed by Purebrush Assoc. with the FDA for Purebrush Ultraviolet Toothbrush Sanitizer.
Device ID | K896481 |
510k Number | K896481 |
Device Name: | PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER |
Classification | Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile |
Applicant | PUREBRUSH ASSOC. EDWARD M. BASILE 1730 PENNSYLVANIA AVENUE, N.W. Washington, DC 20006 |
Contact | & Spalding |
Correspondent | & Spalding PUREBRUSH ASSOC. EDWARD M. BASILE 1730 PENNSYLVANIA AVENUE, N.W. Washington, DC 20006 |
Product Code | MCF |
CFR Regulation Number | 872.6855 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-15 |
Decision Date | 1990-05-15 |