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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Absorbable Synthetic Wound Dressing
510(k) Number K261311
Device Name HYALOMATRIX
Applicant
Anika Therapeutics, Inc.
32 Wiggins Ave.
Beford,  MA  01730
Applicant Contact Wei Zhao
Correspondent
Anika Therapeutics Srl
Corso Stati Uniti 4/U
Padova,  IT 35127
Correspondent Contact Monica Fabris
Classification Product Code
QSZ  
Date Received04/21/2026
Decision Date 09/02/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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