Name: Predicase
Price: 199 USD

K-number	K893126
Device name	DESERET(R) INTRODUCER SET WITH VITACUFF(R) DEVICE
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	LJS
Device class	Class II
Decision date	Aug 10, 1989
Decision	Substantially Equivalent — Same Device
Regulation	880.5970

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Source

View the full FDA submission: accessdata.fda.gov

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DESERET(R) INTRODUCER SET WITH VITACUFF(R) DEVICE

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