The following data is part of a premarket notification filed by Access Pharmaceuticals, Inc with the FDA for Mugard Mucoadhesive Oral Wound Rinse.
| Device ID | K062795 |
| 510k Number | K062795 |
| Device Name: | MUGARD MUCOADHESIVE ORAL WOUND RINSE |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | ACCESS PHARMACEUTICALS, INC 2600 STEMMONS FREEWAY SUITE 176 Dallas, TX 75207 |
| Contact | David Nowotnik, Ph.d. |
| Correspondent | David Nowotnik, Ph.d. ACCESS PHARMACEUTICALS, INC 2600 STEMMONS FREEWAY SUITE 176 Dallas, TX 75207 |
| 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 | 2006-09-18 |
| Decision Date | 2006-12-11 |
| Summary: | summary |