K-number	K982857
Device name	HELAX-IMCON, VERSION 1.0
Applicant	Helax AB
Product code	KPQ
Device class	Class II
Decision date	Nov 4, 1998
Decision	Substantially Equivalent
Regulation	892.5840

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View the full FDA submission: accessdata.fda.gov

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HELAX-IMCON, VERSION 1.0

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