FDA 510(k) Application Details - K001560

Device Classification Name	Unit, Electrosurgical, And Accessories, Dental   More FDA Info for this Device
510(K) Number	K001560
Device Name	Unit, Electrosurgical, And Accessories, Dental
Applicant	ODONTO-WAVE 1136 EAST STUART, #4207 FORT COLLINS, CO 80525 US Other 510(k) Applications for this Company
Contact	JAMES DIEROFF 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	05/19/2000
Decision Date	08/24/2000
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