FDA 510(k), K213198, Ax-Surgi Surgical Hemostat

FDA 510(k), K213198, Ax-Surgi Surgical Hemostat

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510(K) Number: K213198
Device Name: Ax-Surgi Surgical Hemostat
Manufacturer: Leo Mavely
Device Classification Name: Temporary, Internal Use Hemostatic
Regulation Number: POD
Classification Product Code: 09/29/2021
Date Received: 01/05/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery

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