ACRYDERM ABSORBENT OXYGEN DRESSING

Dressing, Wound, Drug

ACRYMED, INC.

The following data is part of a premarket notification filed by Acrymed, Inc. with the FDA for Acryderm Absorbent Oxygen Dressing.

Pre-market Notification Details

Device IDK082459
510k NumberK082459
Device Name:ACRYDERM ABSORBENT OXYGEN DRESSING
ClassificationDressing, Wound, Drug
Applicant ACRYMED, INC. 9560 SW NIMBUS AVE Beaverton,  OR  97008
ContactBruce Gibbins
CorrespondentBruce Gibbins
ACRYMED, INC. 9560 SW NIMBUS AVE Beaverton,  OR  97008
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2008-08-26
Decision Date2008-09-19
Summary:summary

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