The following data is part of a premarket notification filed by Xylos Corporation with the FDA for Xylos Xcell Antimicrobial Dressing.
Device ID | K024054 |
510k Number | K024054 |
Device Name: | XYLOS XCELL ANTIMICROBIAL DRESSING |
Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
Applicant | XYLOS CORPORATION 815 CONNECTICUT AVE., NW. SUITE 800 Washington, DC 20006 |
Contact | Patsy Trisler |
Correspondent | Patsy Trisler XYLOS CORPORATION 815 CONNECTICUT AVE., NW. SUITE 800 Washington, DC 20006 |
Product Code | MGQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-09 |
Decision Date | 2003-03-07 |
Summary: | summary |