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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 K253816
Device Name MuCover (proposed name) Oral Wound Dressing
Applicant
MoleculeX Co., Ltd.
2f, # 18, Ln. 127, Minzu Rd., E. Dist.,
Hsinchu,  TW 300
Applicant Contact ShihYung Liao
Correspondent
ZhengCheng Consulting Limited Company
#19, Fuxing Rd., 335 Ln., Shuling Dist.,
New Taipei,  TW 238
Correspondent Contact Anita Chen
Classification Product Code
OLR  
Date Received11/28/2025
Decision Date 05/21/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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