Name: Predicase
Price: 199 USD

K-number	K061115
Device name	SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216
Applicant	Gvs Spa
Product code	FPA
Device class	Class II
Decision date	Jun 30, 2006
Decision	Substantially Equivalent
Regulation	880.5440

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Source

View the full FDA submission: accessdata.fda.gov

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SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216

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