Name: Predicase
Price: 199 USD

K-number	K103468
Device name	STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)
Applicant	Sorin Group Deutschland GmbH
Product code	DWA
Device class	Class II
Decision date	Jan 20, 2011
Decision	Substantially Equivalent
Regulation	870.4380

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Source

View the full FDA submission: accessdata.fda.gov

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STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)

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