MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY

Dressing, Wound, Drug

DERMA SCIENCES, INC.

The following data is part of a premarket notification filed by Derma Sciences, Inc. with the FDA for Medihoney Gel Dressing With Active Manuka Honey.

Pre-market Notification Details

Device IDK101793
510k NumberK101793
Device Name:MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY
ClassificationDressing, Wound, Drug
Applicant DERMA SCIENCES, INC. 49 PLAIN STREET North Attleboro,  MA  02760
ContactRonald S Warren
CorrespondentRonald S Warren
DERMA SCIENCES, INC. 49 PLAIN STREET North Attleboro,  MA  02760
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2010-06-28
Decision Date2011-02-22
Summary:summary

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