FDA 510(k) Application Details - K972612

Device Classification Name	Device, Neurosurgical Fragmentation And Aspiration   More FDA Info for this Device
510(K) Number	K972612
Device Name	Device, Neurosurgical Fragmentation And Aspiration
Applicant	SATELEC 70 WALNUT ST. WELLESLEY, MA 02481 US Other 510(k) Applications for this Company
Contact	JACKIE MASSE Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/1997
Decision Date	10/08/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review