Submission Details
| 510(k) Number | K874239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 1987 |
| Decision Date | December 29, 1987 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |