Name: Predicase
Price: 199 USD

K-number	K944858
Device name	BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS
Applicant	Baxter Edwards
Product code	DSY
Device class	Class II
Decision date	Jan 5, 1995
Decision	Substantially Equivalent - Subject to Tracking Reg.
Regulation	870.3450

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Source

View the full FDA submission: accessdata.fda.gov

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BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS

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