K896390 is an FDA 510(k) clearance for the WILSON-COOK ESOPHAGEAL PROSTHESIS. This device is classified as a Prosthesis, Esophagus (Class II - Special Controls, product code JCQ).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on December 27, 1989, 51 days after receiving the submission on November 6, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K896390 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 1989 |
| Decision Date | December 27, 1989 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | JCQ — Prosthesis, Esophagus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3610 |