K-number	K020625
Device name	SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346
Applicant	Helena Laboratories
Product code	CIN
Device class	Class II
Decision date	May 6, 2002
Decision	Substantially Equivalent
Regulation	862.1050

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View the full FDA submission: accessdata.fda.gov

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SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346

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