510(k) K083542 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
FRESENIUS STERILE STAY SAFE CAP
| Applicant | Fresenius Medical Care North America, Waltham MA, US |
| Decision | Substantially Equivalent, Dec 29, 2008 |
| Received | Nov 28, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083542
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 7, 2023 | Fresenius Medical Care Holdings, Inc. Stay Safe Cap Open, Classified |
KDJ | None listed |
| Apr 28, 2021 | Fresenius Medical Care Holdings, Inc. 050-95012 Sterile Stay Safe Cap
The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Us Terminated |
KDJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.