The following data is part of a premarket notification filed by Argentum Medical, Llc. with the FDA for Silverlon Ca (calcium Alginate).
| Device ID | K053590 |
| 510k Number | K053590 |
| Device Name: | SILVERLON CA (CALCIUM ALGINATE) |
| Classification | Dressing, Wound, Drug |
| Applicant | ARGENTUM MEDICAL, LLC. 8 TOWER BRIDGE 161 WASHINGTON STREET Conshohocken, PA 19428 |
| Contact | William A Clemnti |
| Correspondent | William A Clemnti ARGENTUM MEDICAL, LLC. 8 TOWER BRIDGE 161 WASHINGTON STREET Conshohocken, PA 19428 |
| 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 | 2005-12-23 |
| Decision Date | 2006-10-06 |
| Summary: | summary |