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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dressing, wound, drug
510(k) Number K222909
Device Name Axiostat Gauze
Applicant
Advamedica Inc.
Harvard Square 1, Mifflin Place,
Suite 400
Cambridge,  MA  02138
Applicant Contact Leo Mavely
Correspondent
Matrix Medical Consulting, Inc.
8880 Rio San Diego Drive,
Suite 800
San Diego,  CA  92108
Correspondent Contact Alan Donald
Classification Product Code
FRO  
Date Received09/26/2022
Decision Date 04/07/2023
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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