FDA 510(k) Application Details - K972019

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K972019
Device Name	Unit, Operative Dental
Applicant	INTERNATIONAL IMAGING ELECTRONICS 881 REMINGTON BLVD. BOLINGBROOK, IL 60440-4932 US Other 510(k) Applications for this Company
Contact	ROGER C CLAAR 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	06/01/1997
Decision Date	07/03/1997
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