Name: Predicase
Price: 199 USD

K-number	K170150
Device name	Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags
Applicant	S.A.L.F. Spa
Product code	KDL
Device class	Class II
Decision date	Oct 20, 2017
Decision	Substantially Equivalent
Regulation	876.5880

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Source

View the full FDA submission: accessdata.fda.gov

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Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags

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