FDA 510(k) Application Details - K000195

Device Classification Name	Motor, Drill, Pneumatic   More FDA Info for this Device
510(K) Number	K000195
Device Name	Motor, Drill, Pneumatic
Applicant	IMAGE-GUIDED NEUROLOGICS, INC. 2290 W. EAU GALLIE BLVD. SUITE 210 MELBOURNE, FL 32935 US Other 510(k) Applications for this Company
Contact	DAVID M LEE Other 510(k) Applications for this Contact
Regulation Number	882.4370   More FDA Info for this Regulation Number
Classification Product Code	HBB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/2000
Decision Date	04/20/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review