FDA 510(k) Application Details - K082532

Device Classification Name	Drill, Bone, Powered   More FDA Info for this Device
510(K) Number	K082532
Device Name	Drill, Bone, Powered
Applicant	STRAUMANN USA 60 MINUTEMAN ROAD ANDOVER, MA 01810 US Other 510(k) Applications for this Company
Contact	ELAINE ALAN Other 510(k) Applications for this Contact
Regulation Number	872.4120   More FDA Info for this Regulation Number
Classification Product Code	DZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/02/2008
Decision Date	10/21/2008
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