The following data is part of a premarket notification filed by Debusk Knitting Mills, Div. Deroyal Industries with the FDA for Deroyal Wound Care Multidex Plus Gel Wound Dressing.
| Device ID | K961085 |
| 510k Number | K961085 |
| Device Name: | DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES 200 DEBUSK LN. Powell, TN 37849 |
| 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 | 1996-03-19 |
| Decision Date | 1996-05-21 |
| Summary: | summary |