The following data is part of a premarket notification filed by Rexaderm, Inc. with the FDA for Rexastom Oral Ease.
| Device ID | K082553 |
| 510k Number | K082553 |
| Device Name: | REXASTOM ORAL EASE |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | REXADERM, INC. 3156 DOOLITTLE DR. Northbrook, IL 60062 |
| Contact | Clyde R Goodheart |
| Correspondent | Clyde R Goodheart REXADERM, INC. 3156 DOOLITTLE DR. Northbrook, IL 60062 |
| 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 | 2008-09-03 |
| Decision Date | 2008-11-21 |
| Summary: | summary |