FDA 510(k) Application Details - K012733

Device Classification Name	Device, Caries Detection   More FDA Info for this Device
510(K) Number	K012733
Device Name	Device, Caries Detection
Applicant	KURARAY MEDICAL INC. 30TH FL. METLIFE BUILDING 200 PARK AVENUE NEW YORK, NY 10166 US Other 510(k) Applications for this Company
Contact	MASAYA SASAKI Other 510(k) Applications for this Contact
Regulation Number	872.1740   More FDA Info for this Regulation Number
Classification Product Code	LFC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/2001
Decision Date	09/14/2001
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