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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.
No.88, Keji 1st Rd., Guishan Dist.
Taoyuan,  TW 33383
Applicant Contact Cheng-Han Zhou
Correspondent
Maxigen Biotech Inc.
No.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
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