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510(k) K261638

Bonvadis® by Oneness Biotech Co., Ltd. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2026
Date Received
May 18, 2026
Clearance Type
Special
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

Other clearances by Oneness Biotech Co., Ltd.

  • K251093 — Bonvadis® (June 9, 2025)

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