K210135 is an FDA 510(k) clearance for the PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing. This device is classified as a Dressing, Wound, Drug.
Submitted by 3M Healthcare Business Group (Berkshire, Bracknell Forest, GB). The FDA issued a Cleared decision on February 24, 2022, 401 days after receiving the submission on January 19, 2021.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K210135 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2021 |
| Decision Date | February 24, 2022 |
| Days to Decision | 401 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |