510(k) K061473 ยท FTL Mesh, Surgical, Polymeric
SURGI-WRAP MAST BIORESORBABLE SHEET
| Applicant | Mast Biosurgery USA, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 21, 2006 |
| Received | May 30, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061473
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2015 | MAST Biosurgery USA, Inc The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm
(01) 18964050255027
(17) 170731(10)52804
LOT 52804 2017-08 REF25502-01
Product is wrapped in a foil pouch that is then se Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.