Name: Predicase
Price: 199 USD

K-number	K090342
Device name	POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400
Applicant	Sophysa SA
Product code	JXG
Device class	Class II
Decision date	Aug 11, 2009
Decision	Substantially Equivalent
Regulation	882.5550

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Source

View the full FDA submission: accessdata.fda.gov

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POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400

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