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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K212766
Device Name Maxiocel Chitosan Wound Dressing
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 Dr. Suite 800
San Diego,  CA  92108
Correspondent Contact Aalan Donald
Classification Product Code
KGN  
Date Received08/31/2021
Decision Date 08/24/2023
Decision Substantially Equivalent (SESE)
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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