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510(k) K231088

Copper Foam Dressing (Prescription and OTC) by Roosin Medical Co., Ltd. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2024
Date Received
April 17, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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