FDA 510(k) Application Details - K000768

Device Classification Name	Unit, Electrosurgical, And Accessories, Dental   More FDA Info for this Device
510(K) Number	K000768
Device Name	Unit, Electrosurgical, And Accessories, Dental
Applicant	WALLACH SURGICAL DEVICES, INC. 235 EDISON RD. ORANGE, CT 06477 US Other 510(k) Applications for this Company
Contact	MICHAEL MALIS 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	03/09/2000
Decision Date	04/11/2000
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