FDA 510(k) Application Details - K013185

Device Classification Name	Handpiece, Belt And/Or Gear Driven, Dental   More FDA Info for this Device
510(K) Number	K013185
Device Name	Handpiece, Belt And/Or Gear Driven, Dental
Applicant	NOUVAG AG 1717 WEST COLLINS AVE. ORANGE, CA 92867 US Other 510(k) Applications for this Company
Contact	COLLEEN BOSWELL Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EFA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2001
Decision Date	11/28/2001
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