FDA 510(k) Application Details - K062897

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K062897
Device Name	Unit, Operative Dental
Applicant	CEFLA S.C.R.L. 110 E GRANADA BLVD. SUITE 207 ORMOND BEACH, FL 32176 US Other 510(k) Applications for this Company
Contact	Claude Berthoin 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	09/27/2006
Decision Date	12/14/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review