510(k) K100261 ยท FRO Dressing, Wound, Drug
PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
| Applicant | Tei Biosciences, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Dec 10, 2010 |
| Received | Jan 28, 2010 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K100261
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2024 | TEI Biosciences, Inc. PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm. Open, Classified |
KGN | None listed |
| Sep 30, 2024 | TEI Biosciences, Inc. PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm. Open, Classified |
KGN | None listed |
| Sep 30, 2024 | TEI Biosciences, Inc. PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1). Open, Classified |
KGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.