Name: Predicase
Price: 199 USD

K-number	K070605
Device name	JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING
Applicant	Maquet Cardiopulmonary, AG
Product code	DTN
Device class	Class II
Decision date	Jan 4, 2008
Decision	Substantially Equivalent
Regulation	870.4400

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Source

View the full FDA submission: accessdata.fda.gov

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JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING

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