FDA 510(k) Application Details - K992898

Device Classification Name	Retractor, Self-Retaining, For Neurosurgery   More FDA Info for this Device
510(K) Number	K992898
Device Name	Retractor, Self-Retaining, For Neurosurgery
Applicant	BRIGHT MEDICAL INSTRUMENTS 799 N.E. 71ST ST. BOCA RATON, FL 33487 US Other 510(k) Applications for this Company
Contact	ROBERT E SIMONSON 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	08/27/1999
Decision Date	10/21/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review