510(k) K161811 ยท PNR Enteral Syringes With Enteral Specific Connectors
Medela Low Dose Enteral Syringe
| Applicant | Medela, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Feb 15, 2017 |
| Received | Jul 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161811
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 5, 2018 | Medela Inc Breast Milk Transfer Lid for use with Oral Syringe Connectors
Model: 90003S-100 Terminated |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.