FDA 510(k) Application Details - K071632

Device Classification Name	Unit, Electrosurgical, And Accessories, Dental   More FDA Info for this Device
510(K) Number	K071632
Device Name	Unit, Electrosurgical, And Accessories, Dental
Applicant	COLTENE/WHALEDENT INC. 235 ASCOT PARKWAY CUYAHOGA FALLS, OH 44223 US Other 510(k) Applications for this Company
Contact	GLENN PERSELLO Other 510(k) Applications for this Contact
Regulation Number	872.4920   More FDA Info for this Regulation Number
Classification Product Code	EKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/14/2007
Decision Date	10/18/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review