FDA 510(k) Application Details - K981390

Device Classification Name	Unit, Electrosurgical, And Accessories, Dental   More FDA Info for this Device
510(K) Number	K981390
Device Name	Unit, Electrosurgical, And Accessories, Dental
Applicant	PERIOGIENE 15825 SHADY GROVE RD. SUITE 90 ROCKVILLE, MD 20850 US Other 510(k) Applications for this Company
Contact	DAVID L WEST 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	04/16/1998
Decision Date	06/11/1998
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