Submission Details
| 510(k) Number | K843114 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Product Development Protocol (SESP) |
| Date Received | August 08, 1984 |
| Decision Date | August 08, 1984 |
| Days to Decision | — |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |