The following data is part of a premarket notification filed by Adri with the FDA for Calgitrol Ag Silver Alginate Wound Dressing.
| Device ID | K011618 |
| 510k Number | K011618 |
| Device Name: | CALGITROL AG SILVER ALGINATE WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | ADRI P.O. BOX 134 Park Forest, IL 60466 |
| Contact | George H Scherr |
| Correspondent | George H Scherr ADRI P.O. BOX 134 Park Forest, IL 60466 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-25 |
| Decision Date | 2002-11-15 |