Name: Predicase
Price: 199 USD

K-number	K170431
Device name	CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip
Applicant	Coeur, Inc.
Product code	DXT
Device class	Class II
Decision date	Aug 18, 2017
Decision	Substantially Equivalent
Regulation	870.1650

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Source

View the full FDA submission: accessdata.fda.gov

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CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip

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