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510(k) K193439

MEBO Wound Dressing by Mebo Life Science, Inc. — Product Code FRO

K193439 is an FDA 510(k) premarket notification submitted by Mebo Life Science, Inc. for the device "MEBO Wound Dressing". The FDA issued a decision of Substantially Equivalent on Sep 4, 2020. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Mebo Life Science, Inc. has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 4, 2020
Date Received
Dec 11, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Review Panel
SU
Submission Type
510(k)

Other clearances by Mebo Life Science, Inc.

  • K222657 — MEBO Wound Dressing (Oct 18, 2022)

Other clearances for product code FRO

  • K254041 — SkinSmart Antimicrobial HydroGel (Sep 11, 2026)
  • K261646 — Redermax® Antibacterial Wound Matrix (Aug 14, 2026)
  • K253665 — Vashe Plus Antimicrobial Solution (Aug 11, 2026)
  • K261023 — Microdacyn Wound Irrigation Solution (Jun 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (Jun 24, 2026)
  • K261638 — Bonvadis® (Jun 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (Apr 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (Mar 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (Mar 13, 2026)

FDA data resources