The following data is part of a premarket notification filed by Argentum Medical, Llc. with the FDA for Silverlon Island Wound Dressing.
| Device ID | K122817 |
| 510k Number | K122817 |
| Device Name: | SILVERLON ISLAND WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | ARGENTUM MEDICAL, LLC. 810 LANDMARK DRIVE SUITE 126 Glen Burnie, MD 21061 |
| Contact | Walt Brittle |
| Correspondent | Walt Brittle ARGENTUM MEDICAL, LLC. 810 LANDMARK DRIVE SUITE 126 Glen Burnie, MD 21061 |
| 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 | 2012-09-14 |
| Decision Date | 2014-05-01 |
| Summary: | summary |