The following data is part of a premarket notification filed by Argentum Medical with the FDA for Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing.
Device ID | K143001 |
510k Number | K143001 |
Device Name: | SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING |
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 | Special |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2014-10-17 |
Decision Date | 2014-11-07 |
Summary: | summary |