Name: Predicase
Price: 199 USD

K-number	K945543
Device name	GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE
Applicant	Intersect Medical Products, Inc.
Product code	CAH
Device class	Class II
Decision date	Nov 29, 1994
Decision	Substantially Equivalent
Regulation	868.5260

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Source

View the full FDA submission: accessdata.fda.gov

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GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE

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