FDA.reportPublic FDA data

510(k) K252167

Device
Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)
Applicant
Qingdao Bright Moon Biomedical Materials Co., Ltd.
510(k) number
K252167
Product code
FRO
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-19
Date received
2025-07-10
Classification name
Dressing, Wound, Drug
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Yunlong Deng
Address
# 788, Bright Moon Rd., Huangdao District Qingdao CN 266499 266499

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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