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U.S. Department of Health and Human Services

Devices@FDA
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Help | Download Files | More about CDRH 510(K)

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Device Classification Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K024054
Device Name XYLOS XCELL ANTIMICROBIAL DRESSING
Applicant
Xylos Corporation
815 Connecticut Ave., NW
Suite 800
Washington,  DC  20006
Applicant Contact Patsy Trisler
Correspondent
Xylos Corporation
815 Connecticut Ave., NW
Suite 800
Washington,  DC  20006
Correspondent Contact Patsy Trisler
Classification Product Code
MGQ  
Date Received12/09/2002
Decision Date 03/07/2003
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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