XYLOS XCELL ANTIMICROBIAL DRESSING

Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

XYLOS CORPORATION

The following data is part of a premarket notification filed by Xylos Corporation with the FDA for Xylos Xcell Antimicrobial Dressing.

Pre-market Notification Details

Device IDK024054
510k NumberK024054
Device Name:XYLOS XCELL ANTIMICROBIAL DRESSING
ClassificationDressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Applicant XYLOS CORPORATION 815 CONNECTICUT AVE., NW. SUITE 800 Washington,  DC  20006
ContactPatsy Trisler
CorrespondentPatsy Trisler
XYLOS CORPORATION 815 CONNECTICUT AVE., NW. SUITE 800 Washington,  DC  20006
Product CodeMGQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-09
Decision Date2003-03-07
Summary:summary

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