Name: Predicase
Price: 199 USD

K-number	K222734
Device name	Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
Applicant	Diversatek Healthcare
Product code	OCX
Device class	Class II
Decision date	Nov 8, 2022
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing

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