Name: Predicase
Price: 199 USD

K-number	K163172
Device name	HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
Applicant	Smiths Medical Asd, Inc.
Product code	DRS
Device class	Class II
Decision date	May 24, 2017
Decision	Substantially Equivalent
Regulation	870.2850

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Source

View the full FDA submission: accessdata.fda.gov

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HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit

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