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510(k) Data Aggregation
K Number
K222657Device Name
MEBO Wound Dressing
Manufacturer
MEBO Life Science Inc.
Date Cleared
2022-10-18
(46 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MEBO Life Science Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx Indications for Use:
For professional use, MEBO Wound Dressing is indicated for management of the following types of wound:
-Skin graft recipient sites
-Newly sutured wounds
-Lacerations and abrasions
-Minor or superficial-partial thickness burns
OTC Indications for Use:
For over-the-counter use, MEBO Wound Dressing is indicated for:
-Minor cuts
-Minor abrasions
-Minor lacerations
-Minor burns
Device Description
The MEBO Wound Dressing is a electron beam irradiation sterilized dressing consisting of sesame oil, beeswax and fabric dressing, which provides a moist environment for wound healing.
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K Number
K193439Device Name
MEBO Wound Dressing
Manufacturer
MEBO Life Science Inc.
Date Cleared
2020-09-04
(268 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MEBO Life Science Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MEBO Wound Dressing is indicated for management of the following types of wound:-Skin graft recipient sites Newly sutured wounds Lacerations and abrasions Minor or superficial-partial thickness burns
Device Description
The MEBO Wound Dressing is a CO60 gamma-radiation sterilized dressing consisting of sesame oil, beeswax and fabric dressing, which provides a moist environment for wound healing.
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