FDA.report

510(k) K253816

Device
MuCover (proposed name) Oral Wound Dressing
Applicant
MoleculeX Co., Ltd.
510(k) number
K253816
Product code
OLR
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-21
Date received
2025-11-28
Classification name
Oral Wound Dressing
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
ShihYung Liao
Address
2f, # 18, Ln. 127, Minzu Rd., E. Dist., Hsinchu TW 300 300

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K191987OrapeuticForward Science2019-11-27
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K130959AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GELBioplax Limited2014-04-04
K112568AONGEN DENTAL COLLAGEN MATRIXAeon Astron Europe B.V.2012-03-01