PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER


Device Classification Name

unit, ultraviolet sanitation/sterilization (for toothbrushes), sterile

510(k) Number K023662
Device Name PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER
Original Applicant
HWADONG INTERNATIONAL COMPANY LTD.
501 s. andrews ave.
ft. lauderdale, 
FL 
33301

Original Contact marian cochran
Regulation Number 872.6855
Classification Product Code
MCF  
Date Received 10/31/2002
Decision Date 05/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No