BIODERM SCIENCES WOUND DRESSING

Dressing, Wound, Drug

BIODERM SCIENCES, INC.

The following data is part of a premarket notification filed by Bioderm Sciences, Inc. with the FDA for Bioderm Sciences Wound Dressing.

Pre-market Notification Details

Device IDK040683
510k NumberK040683
Device Name:BIODERM SCIENCES WOUND DRESSING
ClassificationDressing, Wound, Drug
Applicant BIODERM SCIENCES, INC. 101 ORCHARD RIDGE DR. SUITE 1N Gaithersburg,  MD  20878
ContactEdward R Gubish
CorrespondentEdward R Gubish
BIODERM SCIENCES, INC. 101 ORCHARD RIDGE DR. SUITE 1N Gaithersburg,  MD  20878
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-16
Decision Date2004-06-04
Summary:summary

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