The following data is part of a premarket notification filed by Adri with the FDA for Silversite Or Calgitrol.
| Device ID | K041268 |
| 510k Number | K041268 |
| Device Name: | SILVERSITE OR CALGITROL |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | ADRI 232 MAIN STREET SUITE 11A Park Forest, IL 60466 |
| Contact | George H Scherr, Ph.d. |
| Correspondent | George H Scherr, Ph.d. ADRI 232 MAIN STREET SUITE 11A Park Forest, IL 60466 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-05-12 |
| Decision Date | 2004-09-20 |
| Summary: | summary |