FDA 510(k) Application Details - K020158

Device Classification Name	Zinc Oxide Eugenol   More FDA Info for this Device
510(K) Number	K020158
Device Name	Zinc Oxide Eugenol
Applicant	J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	KEITH A BARRITT Other 510(k) Applications for this Contact
Regulation Number	872.3275   More FDA Info for this Regulation Number
Classification Product Code	EMB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/17/2002
Decision Date	03/07/2002
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