Name: Predicase
Price: 199 USD

K-number	K091656
Device name	SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L
Applicant	Organ Recovery Systems, Inc.
Product code	KDL
Device class	Class II
Decision date	Mar 11, 2010
Decision	Substantially Equivalent
Regulation	876.5880

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Source

View the full FDA submission: accessdata.fda.gov

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SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L

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