K191536 is an FDA 510(k) clearance for the Biatain Silicone Ag. This device is classified as a Dressing, Wound, Drug.
Submitted by Coloplast A/S (Humlebaek, DK). The FDA issued a Cleared decision on February 21, 2020, 256 days after receiving the submission on June 10, 2019.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K191536 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2019 |
| Decision Date | February 21, 2020 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |