The following data is part of a premarket notification filed by 3m Health Care Business Group with the FDA for Promogran Prisma Matrix, Small Dressing, Promogran Prisma Matrix, Large Dressing.
| Device ID | K210135 |
| 510k Number | K210135 |
| Device Name: | PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | 3M Health Care Business Group 3M Centre, Cain Road Berkshire, Bracknell Forest, GB Rg12 8ht, |
| Contact | Margaret Marsh |
| Correspondent | Margaret Marsh 3M Health Care Business Group 3M Centre, Cain Road Berkshire, Bracknell Forest, GB Rg12 8ht, |
| 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 | 2021-01-19 |
| Decision Date | 2022-02-24 |