Submission Details
| 510(k) Number | K872059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 1987 |
| Decision Date | March 16, 1988 |
| Days to Decision | 293 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |