Name: Predicase
Price: 199 USD

K-number	K201533
Device name	Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes
Applicant	Avinent Implant System S.L.U.
Product code	KCT
Device class	Class II
Decision date	Mar 1, 2021
Decision	Substantially Equivalent
Regulation	880.6850

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Source

View the full FDA submission: accessdata.fda.gov

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Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes

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