K-number	K242631
Device name	REGENETEN Bioinductive Implant
Applicant	Smith & Nephew Inc., Endoscopy Div.
Product code	OWY
Device class	Class II
Decision date	Nov 26, 2024
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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REGENETEN Bioinductive Implant

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REGENETEN Bioinductive Implant