Name: Predicase
Price: 199 USD

K-number	K023207
Device name	OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)
Applicant	Toshiba America Medical Systems, In.C
Product code	LNH
Device class	Class II
Decision date	Oct 9, 2002
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)

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