FDA 510(k) Application Details - K043155

Device Classification Name	Unit, Cautery, Thermal, Ac-Powered   More FDA Info for this Device
510(K) Number	K043155
Device Name	Unit, Cautery, Thermal, 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	886.4115   More FDA Info for this Regulation Number
Classification Product Code	HQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2004
Decision Date	12/09/2004
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