The following data is part of a premarket notification filed by Xylos Corporation with the FDA for X-cell Wound Dressing.
| Device ID | K974251 |
| 510k Number | K974251 |
| Device Name: | X-CELL WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | XYLOS CORPORATION 29 AINSWORTH AVE. East Burnswick, NJ 08816 |
| Contact | Eric Flam |
| Correspondent | Eric Flam XYLOS CORPORATION 29 AINSWORTH AVE. East Burnswick, NJ 08816 |
| 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 | 1997-11-13 |
| Decision Date | 1998-06-22 |
| Summary: | summary |