Submission Details
| 510(k) Number | K830339 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 01, 1983 |
| Decision Date | April 12, 1983 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
K830339 is an FDA 510(k) clearance for the IMSI/METRIPOND HAND OPERATING TABLE, a Table, Operating-room, Manual (Class I — General Controls, product code FSE), submitted by Intl. Management Services, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 12, 1983, 70 days after receiving the submission on February 1, 1983. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.
| 510(k) Number | K830339 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 01, 1983 |
| Decision Date | April 12, 1983 |
| Days to Decision | 70 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 |