The following data is part of a premarket notification filed by Argentum Medical with the FDA for Silverlon Burn Contact Dressings.
| Device ID | K150256 |
| 510k Number | K150256 |
| Device Name: | SILVERLON BURN CONTACT DRESSINGS |
| Classification | Dressing, Wound, Drug |
| Applicant | ARGENTUM MEDICAL 2571 KANEVILLE COURT Geneva, IL 60134 |
| Contact | C.richard Foster |
| Correspondent | C.richard Foster ARGENTUM MEDICAL 2571 KANEVILLE COURT 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 | 2015-02-03 |
| Decision Date | 2015-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00714196939111 | K150256 | 000 |
| 00714196550446 | K150256 | 000 |
| 00714196393081 | K150256 | 000 |