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In this section: Substantially Equivalent 510(k) Device Information

BR220665 - HEMANEXT ONE

De Novo Number: BR220665
Applicant: Hemanext, Inc.
Device Name: HEMANEXT ONE
Decision Date: 9/15/2023

Supporting Documents

BR220665 De Novo Classification Order
BR220665 De Novo Decision Summary
BR220665 Package Insert

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