510(k) K142097 ยท FPA Set, Administration, Intravascular
SELEC-3 I.V.ADMINISTRATION SET
| Applicant | Biomedix, Inc., Blmgtn IN, US |
| Decision | Substantially Equivalent, Aug 29, 2014 |
| Received | Aug 1, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142097
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2014 | Biomedix, Inc. Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.