K863666 is an FDA 510(k) clearance for the THE SAVER KIT..
Submitted by Myocure, Inc. (Glendale, US). The FDA issued a Cleared decision on October 20, 1986, 32 days after receiving the submission on September 18, 1986.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K863666 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 1986 |
| Decision Date | October 20, 1986 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | — |
| Device Class | — |