FDA 510(k) Application Details - K010255

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K010255
Device Name	Varnish, Cavity
Applicant	RITE-DENT MANUFACTURING CORP. 1056 EAST 33RD ST. HIALEAH, FL 33013-3526 US Other 510(k) Applications for this Company
Contact	CESAR E VELIZ Other 510(k) Applications for this Contact
Regulation Number	872.3260   More FDA Info for this Regulation Number
Classification Product Code	LBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/29/2001
Decision Date	04/20/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review