K-number	K231787
Device name	ecoFIX®
Applicant	Science & Bio Materials (S.B.M.) Sas
Product code	MAI
Device class	Class II
Decision date	Jul 26, 2023
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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ecoFIX®

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