FDA 510(k) Application Details - K041458

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K041458
Device Name	Unit, Operative Dental
Applicant	DENIMED ELECTRONICA S.H. 1460 NW 107 AVE. SUITE G MIAMI, FL 33172 US Other 510(k) Applications for this Company
Contact	GEORGE ECHEVERRI Other 510(k) Applications for this Contact
Regulation Number	872.6640   More FDA Info for this Regulation Number
Classification Product Code	EIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2004
Decision Date	08/24/2004
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