510(k) K173276 ยท FRO Dressing, Wound, Drug
Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP
| Applicant | Medline Industries, Inc., Northfiled IL, US |
| Decision | Substantially Equivalent, Jul 2, 2018 |
| Received | Oct 12, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173276
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Sterile Water, USP, 100mL, REF RDI30295 Open, Classified |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.