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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oral Wound Dressing
510(k) Number K230529
Device Name HealiAid Dental Collagen Wound Dressing
Applicant
Maxigen Biotech, Inc.
#88, Keji 1st Rd., Guishan Dist.,
Taoyuan,  TW 33383
Applicant Contact Cheng-Han Zhou
Correspondent
Maxigen Biotech, Inc.
#88, Keji 1st Rd., Guishan Dist.,
Taoyuan,  TW 33383
Correspondent Contact Cheng-Han Zhou
Classification Product Code
OLR  
Date Received02/27/2023
Decision Date 11/22/2023
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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