Name: Predicase
Price: 199 USD

K-number	K112887
Device name	UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR
Applicant	Upstream Peripheral Technologies
Product code	DYB
Device class	Class II
Decision date	Mar 21, 2012
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR

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