FDA 510(k) Application Details - K080130

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K080130
Device Name	Material, Impression
Applicant	ZHERMACK S.P.A. 19379 BLUE LAKE LOOP BEND, OR 97702 US Other 510(k) Applications for this Company
Contact	GERALD W SHIPPS Other 510(k) Applications for this Contact
Regulation Number	872.3660   More FDA Info for this Regulation Number
Classification Product Code	ELW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/18/2008
Decision Date	03/14/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review