The following data is part of a premarket notification filed by Argentum Medical, Llc with the FDA for Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also Known As Silverlon Burn Pad Dressing).
| Device ID | K180570 |
| 510k Number | K180570 |
| Device Name: | Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also Known As Silverlon Burn Pad Dressing) |
| Classification | Dressing, Wound, Drug |
| Applicant | Argentum Medical, LLC 2571 Kaneville CT Geneva, IL 60134 |
| Contact | Paul Boentges |
| Correspondent | Kartik Patel Argentum Medical, LLC 2571 Kaneville CT Geneva, IL 60134 |
| 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 | 2018-03-05 |
| Decision Date | 2019-01-14 |
| Summary: | summary |