The following data is part of a premarket notification filed by Dpt Laboratories, Ltd. with the FDA for Curasol Gel Wound Dressing.
| Device ID | K953450 |
| 510k Number | K953450 |
| Device Name: | CURASOL GEL WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | DPT LABORATORIES, LTD. 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer DPT LABORATORIES, LTD. 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
| 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 | 1995-07-18 |
| Decision Date | 1995-08-07 |