FDA 510(k) Application Details - K971642

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K971642
Device Name	Cement, Dental
Applicant	NEO DENTAL CHEMICAL PRODUCTS CO., LTD. 7613 CARTERET RD. BETHESDA, MD 20817 US Other 510(k) Applications for this Company
Contact	KYLE H SIBINOVIC 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	05/02/1997
Decision Date	07/24/1997
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