FDA 510(k) Application Details - K974487

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K974487
Device Name	Unit, Operative Dental
Applicant	ASI MEDICAL, INC. 14550 EAST EASTER AVE. SUITE 700 ENGLEWOOD, CO 80112 US Other 510(k) Applications for this Company
Contact	JOHN W MCPEEK 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	11/26/1997
Decision Date	02/18/1998
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