FDA 510(k) Application Details - K050308

Device Classification Name	Apparatus, Cautery, Radiofrequency, Ac-Powered   More FDA Info for this Device
510(K) Number	K050308
Device Name	Apparatus, Cautery, Radiofrequency, Ac-Powered
Applicant	STARION INSTRUMENTS 20665 4TH ST. SARATOGA, CA 95070 US Other 510(k) Applications for this Company
Contact	BRIAN GRIGSBY Other 510(k) Applications for this Contact
Regulation Number	886.4100   More FDA Info for this Regulation Number
Classification Product Code	HQR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2005
Decision Date	02/25/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review