Submission Details
| 510(k) Number | K861343 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 07, 1986 |
| Decision Date | July 17, 1986 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
K861343 is an FDA 510(k) clearance for the R1618, R1619 & R1654 ICE MAKING MACHINES, submitted by Tri W-G, Inc. (Valley City, US). The FDA issued a Cleared decision on July 17, 1986, 101 days after receiving the submission on April 7, 1986. This device falls under the Physical Medicine review panel.
| 510(k) Number | K861343 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 07, 1986 |
| Decision Date | July 17, 1986 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | — |
| Device Class | — |