FDA 510(k) Application Details - K970205

Device Classification Name	Alloy, Metal, Base   More FDA Info for this Device
510(K) Number	K970205
Device Name	Alloy, Metal, Base
Applicant	AUSTENAL, INC. 4101 WEST 51ST ST. CHICAGO, IL 60632-4287 US Other 510(k) Applications for this Company
Contact	RONALD DUDEK Other 510(k) Applications for this Contact
Regulation Number	872.3710   More FDA Info for this Regulation Number
Classification Product Code	EJH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/1997
Decision Date	04/21/1997
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