FDA 510(k) Application Details - K032607

Device Classification Name	Drill, Bone, Powered   More FDA Info for this Device
510(K) Number	K032607
Device Name	Drill, Bone, Powered
Applicant	LINVATEC CORP. 11311 CONCEPT BLVD. LARGO, FL 33773-4908 US Other 510(k) Applications for this Company
Contact	LAURA KREJCI 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	08/25/2003
Decision Date	11/10/2003
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