FDA 510(k) Application Details - K093352

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K093352
Device Name	Implant, Endosseous, Root-Form
Applicant	HIOSSEN INC. 85 BEN FAIRLESS DRIVE FAIRLESS HILLS, PA 19030 US Other 510(k) Applications for this Company
Contact	PATRICK LIM Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/27/2009
Decision Date	11/24/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review