FDA.reportPublic FDA data

510(k) K220673

Device
Sterile Silver Alginate Wound Dressing
Applicant
Qingdao Bright Moon Biomedical Materials Co., Ltd.
510(k) number
K220673
Product code
FRO
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-16
Date received
2022-03-07
Classification name
Dressing, Wound, Drug
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Deng Yunlong
Address
# 788, Bright Moon Rd., Huangdao District Qingdao CN 266400 266400

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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