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510(k) Data Aggregation
K Number
K133729Device Name
WOUND DRESSING WITH MANUKA HONEY
Manufacturer
Date Cleared
2015-01-23
(413 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MANUKA HEALTH NEW ZEALAND LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Wound Dressing with Manuka Honey is indicated for use in management of wounds. Full and partial thickness wounds, pressure ulcers (stages I-IV), venous stasis ulcers, diabetic ulcers, abrasions, surface wounds, traumatic wounds (healing by secondary intention), donor site wounds and surgical wounds. For single-use only.
Wound Dressing with Manuka Honey is indicated for minor abrasions, minor scalds, and minor burns. For single-use only.
Device Description
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