Name: Predicase
Price: 199 USD

K-number	K210342
Device name	BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor
Applicant	STERIS Corporation
Product code	ODC
Device class	Class II
Decision date	Sep 3, 2021
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor

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