510(k) K862203 ยท LCJ Tissue Expander And Accessories
MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER
| Applicant | Mcghan Medical Corp., Santa Barbara CA, US |
| Decision | Substantially Equivalent, Jul 23, 1986 |
| Received | Jun 10, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862203
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2019 | Allergan PLC Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion S Open, Classified |
LCJ | None listed |
| Sep 11, 2019 | Allergan PLC Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set
STYLE 133FV-T:
133FV-11-T,
133FV-12-T,
133FV-13-T,
133FV-14-T,
133 Open, Classified |
LCJ | None listed |
| Sep 11, 2019 | Allergan PLC McGhan Croissant-Shaped Tissue Expanders, Style 134
Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection unti Open, Classified |
LCJ | None listed |
| Jul 18, 2015 | Allergan Inc Natrelle 133 Series Tissue Expanders
Product Usage:
Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile sa Terminated |
LCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.