FDA 510(k) Application Details - K990479

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K990479
Device Name	Unit, Operative Dental
Applicant	HYGENITEK, INC. 7370 WOODBINE AVE. UNIT 5 MARKHAM, ONTARIO L3R1A5 CA Other 510(k) Applications for this Company
Contact	KATIE LUBIN Other 510(k) Applications for this Contact
Regulation Number	872.6640   More FDA Info for this Regulation Number
Classification Product Code	EIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/1999
Decision Date	05/13/1999
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