MEBO Wound Dressing

FDA 510(k) K193439 · Mebo Life Science, Inc.

Substantially Equivalent

510(k) numberK193439

Submission

Device name
MEBO Wound Dressing
Applicant
Mebo Life Science, Inc.
Brea, CA, US
Received
December 11, 2019
Decision date
September 4, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRO – Dressing, Wound, Drug
Device class
Unclassified

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Questions and answers

When was MEBO Wound Dressing cleared by the FDA?

MEBO Wound Dressing (K193439) received a 510(k) decision of Substantially Equivalent on September 4, 2020, 268 days after the submission was received.

What is the product code of K193439?

The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.