FDA 510(k) Application Details - K071771

Device Classification Name	Retractor, Self-Retaining, For Neurosurgery   More FDA Info for this Device
510(K) Number	K071771
Device Name	Retractor, Self-Retaining, For Neurosurgery
Applicant	INSTRUMED INTERNATIONAL, INC. 626 COOPER COURT SCHAUMBURG, IL 60173 US Other 510(k) Applications for this Company
Contact	MICHAEL MASSONG Other 510(k) Applications for this Contact
Regulation Number	882.4800   More FDA Info for this Regulation Number
Classification Product Code	GZT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2007
Decision Date	08/02/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review