BIODERM SCIENCES WOUND CREAM

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 Cream.

Pre-market Notification Details

Device IDK042352
510k NumberK042352
Device Name:BIODERM SCIENCES WOUND CREAM
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 ProductYes
Date Received2004-08-30
Decision Date2005-10-17
Summary:summary

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