FDA 510(k) Application Details - K010935

Device Classification Name	Dam, Rubber   More FDA Info for this Device
510(K) Number	K010935
Device Name	Dam, Rubber
Applicant	BRITESMILE, INC. 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	SHEILA HEMEON-HEYER Other 510(k) Applications for this Contact
Regulation Number	872.6300   More FDA Info for this Regulation Number
Classification Product Code	EIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2001
Decision Date	09/05/2001
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