BIODERM SCIENCES WOUND HEALING SPRAY

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 Healing Spray.

Pre-market Notification Details

Device IDK042084
510k NumberK042084
Device Name:BIODERM SCIENCES WOUND HEALING SPRAY
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 Received2004-08-03
Decision Date2005-06-15
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.