K-number	K242250
Device name	PuraStat
Applicant	3-D Matrix Europe SAS
Product code	QAU
Device class	Class II
Decision date	Oct 22, 2024
Decision	Substantially Equivalent
Regulation	878.4456

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Source

View the full FDA submission: accessdata.fda.gov

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PuraStat

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