FDA 510(k) Application Details - K040797

Device Classification Name	Dam, Rubber   More FDA Info for this Device
510(K) Number	K040797
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	03/29/2004
Decision Date	04/02/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review