510(k) K073251 ยท QSZ Absorbable Synthetic Wound Dressing
HYALOMATRIX PA
| Applicant | Fidia Advanced Biopolymers Srl, Washington DC, US |
| Decision | Substantially Equivalent, Dec 14, 2007 |
| Received | Nov 19, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073251
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2018 | Anika Therapeutics, Inc. Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301
Product Usage:
Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. Terminated |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.