Submission Details
| 510(k) Number | K821924 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 29, 1982 |
| Decision Date | July 13, 1982 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
K821924 is an FDA 510(k) clearance for the TABLE, OPERATING, FIELD 6530-00-709-8155, a Table, Operating-room, Manual (Class I — General Controls, product code FSE), submitted by Emerson-Sack-Warner Corp. (Mchenry, US). The FDA issued a Cleared decision on July 13, 1982, 14 days after receiving the submission on June 29, 1982. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.
| 510(k) Number | K821924 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 29, 1982 |
| Decision Date | July 13, 1982 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FSE — Table, Operating-room, Manual |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4950 |