510(k) K143354 ยท LCJ Tissue Expander And Accessories
Natrelle 133 Plus Tissue Expander
| Applicant | Allergan, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Aug 20, 2015 |
| Received | Nov 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143354
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2019 | Allergan PLC Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers:
STYLE 133 Open, Classified |
LCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.