FDA 510(k) Application Details - K032455

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K032455
Device Name	Cement, Dental
Applicant	KURARAY MEDICAL INC. 101 EAST 52ND STREET, 26TH FL. NEW YORK, NY 10022 US Other 510(k) Applications for this Company
Contact	SATOSHI YAMAGUCHI Other 510(k) Applications for this Contact
Regulation Number	872.3275   More FDA Info for this Regulation Number
Classification Product Code	EMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/2003
Decision Date	11/07/2003
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