Name: Predicase
Price: 199 USD

K-number	K051232
Device name	D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER
Applicant	Dideco S.R.L.
Product code	DTM
Device class	Class II
Decision date	May 20, 2005
Decision	Substantially Equivalent
Regulation	870.4260

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Source

View the full FDA submission: accessdata.fda.gov

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D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER

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