The following data is part of a premarket notification filed by Hwadong International Company Ltd. with the FDA for Prosonic Ultraviolet Toothbrush Sanitizer.
| Device ID | K023662 |
| 510k Number | K023662 |
| Device Name: | PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER |
| Classification | Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile |
| Applicant | HWADONG INTERNATIONAL COMPANY LTD. 501 S. ANDREWS AVE. Ft. Lauderdale, FL 33301 |
| Contact | Marian Cochran |
| Correspondent | Marian Cochran HWADONG INTERNATIONAL COMPANY LTD. 501 S. ANDREWS AVE. Ft. Lauderdale, FL 33301 |
| Product Code | MCF |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-31 |
| Decision Date | 2003-05-28 |
| Summary: | summary |