The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Algidex Ag Silver Alginate Wound Dressing.
| Device ID | K173072 |
| 510k Number | K173072 |
| Device Name: | Algidex Ag Silver Alginate Wound Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849 |
| Contact | Sarah Bennett |
| Correspondent | Sarah Bennett DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2017-09-29 |
| Decision Date | 2018-04-04 |
| Summary: | summary |