FDA 510(k) Application Details - K000140

Device Classification Name	Eraser, Dental Stain   More FDA Info for this Device
510(K) Number	K000140
Device Name	Eraser, Dental Stain
Applicant	THE PRECIDENT GROUP 200 WESTPARK CORPORATE CENTER 4364 SOUTH ALSTON AVENUE DURHAM, NC 27713-2280 US Other 510(k) Applications for this Company
Contact	WENDY BEDALE Other 510(k) Applications for this Contact
Regulation Number	872.6855   More FDA Info for this Regulation Number
Classification Product Code	MAU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/18/2000
Decision Date	05/03/2000
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