The following data is part of a premarket notification filed by Argentum Medical, Inc. with the FDA for Silverlon Wound Contact, Burn Contact Dressings.
| Device ID | K221218 |
| 510k Number | K221218 |
| Device Name: | Silverlon Wound Contact, Burn Contact Dressings |
| Classification | Dressing, Wound, Drug |
| Applicant | Argentum Medical, Inc. 2571 Kaneville Ct Geneva, IL 60134 |
| Contact | Kathy Herzog |
| Correspondent | Kathy Herzog Argentum Medical, Inc. 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 | 2022-04-27 |
| Decision Date | 2022-10-26 |