FDA 510(k) Application Details - K021383

Device Classification Name	Toothbrush, Manual   More FDA Info for this Device
510(K) Number	K021383
Device Name	Toothbrush, Manual
Applicant	AGION TECHNOLOGIES, LLC. 60 AUDUBON RD. WAKEFIELD, MA 01880 US Other 510(k) Applications for this Company
Contact	PAUL C FORD Other 510(k) Applications for this Contact
Regulation Number	872.6855   More FDA Info for this Regulation Number
Classification Product Code	EFW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2002
Decision Date	07/17/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review