FDA 510(k) Application Details - K021869

Device Classification Name	Generator, Lesion, Radiofrequency   More FDA Info for this Device
510(K) Number	K021869
Device Name	Generator, Lesion, Radiofrequency
Applicant	DIROS TECHNOLOGY, INC. 1837 KEMPTON RD. CHARLESTON, SC 29412 US Other 510(k) Applications for this Company
Contact	LESLIE W ORGAN Other 510(k) Applications for this Contact
Regulation Number	882.4400   More FDA Info for this Regulation Number
Classification Product Code	GXD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2002
Decision Date	07/01/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review