Submission Details
| 510(k) Number | K844467 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 19, 1984 |
| Decision Date | February 22, 1985 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
K844467 is an FDA 510(k) clearance for the OMS CRYO, submitted by Optical Micro Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on February 22, 1985, 95 days after receiving the submission on November 19, 1984. This device falls under the Dental review panel.
| 510(k) Number | K844467 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 19, 1984 |
| Decision Date | February 22, 1985 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | — |
| Device Class | — |