FDA 510(k) Application Details - K073539

Device Classification Name	Zinc Oxide Eugenol   More FDA Info for this Device
510(K) Number	K073539
Device Name	Zinc Oxide Eugenol
Applicant	CAVEX HOLLAND B.V. PO BOX 852 HAARLEM (HOLLAND) 2003 RW NL Other 510(k) Applications for this Company
Contact	RICHARD WOORTMAN 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	12/17/2007
Decision Date	01/31/2008
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