510(k) K120836 ยท NGT Saline, Vascular Access Flush
0.9% SODIUM CHLORIDE FLISH SYRINGE
| Applicant | Am USA, Nashville TN, US |
| Decision | Substantially Equivalent, Jul 12, 2012 |
| Received | Mar 20, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120836
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2015 | MRP, LLC dba AMUSA 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution. Terminated |
NGT | None listed |
| Jun 15, 2015 | MRP, LLC dba AMUSA T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706
Usage: Flush syringe. Terminated |
NGT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.