Name: Predicase
Price: 199 USD

K-number	K980386
Device name	HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)
Applicant	Gambro Healthcare
Product code	KDI
Device class	Class II
Decision date	Feb 24, 1999
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)

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