Name: Predicase
Price: 199 USD

K-number	K050255
Device name	ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4
Applicant	Gendex Dental Systems
Product code	EHD
Device class	Class II
Decision date	Mar 17, 2005
Decision	Substantially Equivalent
Regulation	872.1800

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Source

View the full FDA submission: accessdata.fda.gov

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ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4

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