FDA 510(k) Application Details - K072213

Device Classification Name	Handpiece, Direct Drive, Ac-Powered   More FDA Info for this Device
510(K) Number	K072213
Device Name	Handpiece, Direct Drive, Ac-Powered
Applicant	PERIMETRICS, INC. 27001 LA PAZ, SUITE 314 MISSION VIEJO, CA 92691 US Other 510(k) Applications for this Company
Contact	ALBERT REGO Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2007
Decision Date	08/29/2008
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