Name: Predicase
Price: 199 USD

K-number	K952270
Device name	DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN
Applicant	Sorin Biomedical, Inc.
Product code	DTM
Device class	Class II
Decision date	Aug 21, 1995
Decision	Substantially Equivalent
Regulation	870.4260

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Source

View the full FDA submission: accessdata.fda.gov

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DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN

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