510(k) K990428 ยท EXF Bag, Bile Collecting
DRAINAGE BAG
| Applicant | Remington Medical, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Aug 12, 1999 |
| Received | Feb 11, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990428
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 5, 2023 | Remington Medical, Inc. Remington MEDICAL Drainage Bag, REF 600-D; Open, Classified |
EXF | None listed |
| Oct 23, 2007 | Remington Medical Inc. Remington Medical, Inc, (RMI) -- Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number: 500-D) and 1000ml Disposible Urinary Leg Bag (Order number 1000-D) -- Sterile Fluid Path, For S Terminated |
EXF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.