FDA 510(k) Application Details - K981144

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K981144
Device Name	Unit, Operative Dental
Applicant	AQUARIUS TECHNOLOGIES, INC. 1822 SUNSET PL. LONGMONT, CO 80501 US Other 510(k) Applications for this Company
Contact	WILLIAM JEFFERS 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	03/30/1998
Decision Date	09/15/1998
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