Name: Predicase
Price: 199 USD

K-number	K162573
Device name	Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source
Applicant	Source Production and Equipment Co., Inc.
Product code	KXK
Device class	Class II
Decision date	Nov 4, 2016
Decision	Substantially Equivalent
Regulation	892.5730

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Source

View the full FDA submission: accessdata.fda.gov

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Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source

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