FDA 510(k) Application Details - K033419

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K033419
Device Name	Unit, Operative Dental
Applicant	TROPHY RADIOLOGIE 4 RUE F. PELLOUTIER CROISSY-BEAUBOURG MARNE LA VALLEE CEDEX 2 77437 FR Other 510(k) Applications for this Company
Contact	MARIE-PIERRE LABAT-CAMY 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	10/27/2003
Decision Date	02/02/2004
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