K935096 is an FDA 510(k) clearance for the BIOLEX IMPREGNATED WOUND DRESSING. This device is classified as a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic.
Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on February 17, 1994, 118 days after receiving the submission on October 22, 1993.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K935096 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 1993 |
| Decision Date | February 17, 1994 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MGQ — Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Device Class | — |