510(k) K070560 ยท FTM Mesh, Surgical
LRTM SURGICAL MESH
| Applicant | Lifecell Corp., Branchburg NJ, US |
| Decision | Substantially Equivalent, Jun 11, 2007 |
| Received | Feb 27, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070560
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2011 | LifeCell Corporation LifeCell Strattice Reconstructive Tissue Matrix for Stoma Reinforcement
Catalog #0606008 (6 x 6 cm), 0808008 (8 cm x 8 cm), (0610008 ( 6 cm x 10 cm).
Intended for use as a soft tissue patch to reinfo Terminated |
FTM | None listed |
| Sep 29, 2010 | LifeCell Corporation Strattice Reconstructive Tissue Matrix for Stoma Reinforcement.
8 cm x 8 cm
Packaged in an inner foil pouch inside outer foil pouch tertiary carton.
LifeCell Corporation, One Millennium Way, Branchbur Terminated |
FTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.