DERMA SCIENCES MEDIHONEY DRESSINGS 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 Derma Sciences Medihoney Dressings With Active Manuka Honey.

Pre-market Notification Details

Device IDK080315
510k NumberK080315
Device Name:DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
ClassificationDressing, Wound, Drug
Applicant DERMA SCIENCES, INC. 49 PLAIN ST. North Attleboro,  MA  02760
ContactMary Mcnamara-cullinane
CorrespondentMary Mcnamara-cullinane
DERMA SCIENCES, INC. 49 PLAIN ST. North Attleboro,  MA  02760
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2008-02-06
Decision Date2008-04-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30381780486835 K080315 000

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