510(k) K970187 ยท LRO General Surgery Tray
RUNYON LARGE VOLUME PARACENTESIS KIT
| Applicant | Gi Supply, Willington CT, US |
| Decision | Substantially Equivalent, Feb 14, 1997 |
| Received | Jan 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970187
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2016 | Gi Supply Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag.
Catalog #: GIS-28
Lot #: 61442434
Expiratio Terminated |
LRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.