Name: Predicase
Price: 199 USD

K-number	K980417
Device name	MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V
Applicant	Medrad, Inc.
Product code	LNH
Device class	Class II
Decision date	May 4, 1998
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V

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