Name: Predicase
Price: 199 USD

K-number	K062441
Device name	BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020
Applicant	Barrx Medical, Incorporated
Product code	GEI
Device class	Class II
Decision date	Nov 14, 2006
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020

Everything you need for a 510(k) submission. Nothing you don't.