K-number	K022455
Device name	SPIFE LD-12 KIT, MODEL 3338
Applicant	Helena Laboratories
Product code	CFE
Device class	Class II
Decision date	Oct 1, 2002
Decision	Substantially Equivalent
Regulation	862.1445

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View the full FDA submission: accessdata.fda.gov

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SPIFE LD-12 KIT, MODEL 3338

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