K-number	K013466
Device name	SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343
Applicant	Helena Laboratories
Product code	JHO
Device class	Class I
Decision date	Dec 21, 2001
Decision	Substantially Equivalent
Regulation	862.1475

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SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343

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