Name: Predicase
Price: 199 USD

K-number	K242742
Device name	DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
Applicant	STERIS Corporation
Product code	ODC
Device class	Class II
Decision date	Oct 11, 2024
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)

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