Submission Details
| 510(k) Number | K890314 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1989 |
| Decision Date | February 27, 1989 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |