Name: Predicase
Price: 199 USD

K-number	K071378
Device name	MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
Applicant	E-Z-Em, Inc.
Product code	JAK
Device class	Class II
Decision date	Jun 13, 2007
Decision	Substantially Equivalent
Regulation	892.1750

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View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES

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