Submission Details
| 510(k) Number | K854920 FDA.gov |
| FDA Decision | Cleared SN |
| Date Received | December 10, 1985 |
| Decision Date | May 19, 1986 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
K854920 is an FDA 510(k) clearance for the THERAPY CASSETTS, submitted by Alpha Therapeutic Corp. (Rouses Point, US). The FDA issued a Cleared decision on May 19, 1986, 160 days after receiving the submission on December 10, 1985. This device falls under the Cardiovascular review panel.
| 510(k) Number | K854920 FDA.gov |
| FDA Decision | Cleared SN |
| Date Received | December 10, 1985 |
| Decision Date | May 19, 1986 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | MCU |
| Device Class | — |