Name: Predicase
Price: 199 USD

K-number	K180021
Device name	Proton Positioing and Immobilization Devices
Applicant	Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap
Product code	IYE
Device class	Class II
Decision date	Jun 29, 2018
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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Proton Positioing and Immobilization Devices

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