K-number	K000881
Device name	PERFADEX SOLUTION FOR ORGAN PRESERVATION
Applicant	Vitrolife Sweden AB
Product code	MSB
Device class	Class II
Decision date	Mar 8, 2001
Decision	Substantially Equivalent
Regulation	876.5880

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Source

View the full FDA submission: accessdata.fda.gov

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PERFADEX SOLUTION FOR ORGAN PRESERVATION

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