ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL


Device Classification Name

toothbrush, manual

510(k) Number K021383
Device Name ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
Original Applicant
AGION TECHNOLOGIES, LLC.
60 audubon rd.
wakefield, 
MA 
01880

Original Contact paul c ford
Regulation Number 872.6855
Classification Product Code
EFW  
Date Received 05/02/2002
Decision Date 07/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No