510(k) K900035 ยท FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation
WILSON-COOK COLON DECOMPRESSION SET
| Applicant | Wilson-Cook Medical, Inc., Winston-Salem NC, US |
| Decision | Substantially Equivalent, Mar 7, 1990 |
| Received | Jan 2, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900035
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2006 | EM Innovations Inc Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick-on label on device and User Instruction sheet are attached to the case with a rubber band. Terminated |
MMK | None listed |
| Oct 22, 2003 | Wilson-Cook Medical Inc Brodmerkel Colon Decompression Set, CDSB-10, Catheter Diameter: 10 Fr. Catheter Length: 350 cm. Sideports: 10, Standard wire Guide: .035''/480 cm. Disposable Single use only, Rx Only. Cook, Wilson-Co Terminated |
FEG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.