FDA Approval of Manuka Honey | Treatment of Wounds

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for Manuka Honey:

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FDA Approval of Manuka

Source: Center for Devices and Radiological Health / CDRH web database http://www.fda.gov/cdrh/ 510(k) Premarket Notification Database
Device Classification	Name dressing, wound, drug
510(k) Number	K080315
Device Name	DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
Applicant	DERMA SCIENCES, INC. 49 plain st. north attleboro, MA 02760
Contact	mary mcnamara-cullinane
Classification Product Code	FRO
Date Received	02/06/2008
Decision Date	04/23/2008
Decision	substantially equivalent (SE)
Classification Advisory Committee	General & Plastic Surgery
Review Advisory Committee	General & Plastic Surgery
Statement/Summary/Purged Status	Summary Only
summary	summary
Type	Traditional
Reviewed by Third Party	No
Expedited Review	No

Manuka Honey is approved by the FDA for human consumption.

Do not give Manuka Honey to children under the age of one.

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