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510(k) K252028

LUOFUCON® Antimicrobial Wound Gel by Huizhou Foryou Medical Co., Ltd. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2026
Date Received
June 30, 2025
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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