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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary, Internal Use Hemostatic
510(k) Number K213198
Device Name Ax-Surgi Surgical Hemostat
Applicant
Advamedica, Inc.
Harvard Square 1, Mifflin Place,
Suite 400
Cambridge,  MA  02138
Applicant Contact Leo Mavely
Correspondent
Alira Health
Avinguda Josep Tarradellas
123 (7th Floor)
Barcelona,  ES 08029
Correspondent Contact Ainoa Forteza
Regulation Number878.4454
Classification Product Code
POD  
Date Received09/29/2021
Decision Date 01/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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