K-number	K230266
Device name	Orchid Safety Release Valve
Applicant	Linear Health Sciences, LLC
Product code	QOI
Device class	Class II
Decision date	May 4, 2023
Decision	Substantially Equivalent
Regulation	880.5220

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Source

View the full FDA submission: accessdata.fda.gov

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Orchid Safety Release Valve

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