Name: Predicase
Price: 199 USD

K-number	K062887
Device name	MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F
Applicant	Bard Peripheral Vascular
Product code	DTK
Device class	Class II
Decision date	Oct 26, 2006
Decision	Substantially Equivalent
Regulation	870.3375

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F

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