Submission Details
| 510(k) Number | K883680 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 29, 1988 |
| Decision Date | October 04, 1988 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
K883680 is an FDA 510(k) clearance for the MEDALIST EXAMINATION TABLE, a Table, Examination, Medical, Powered (Class I — General Controls, product code LGX), submitted by Hamilton Industries, Inc. (Two Rivers, US). The FDA issued a Cleared decision on October 4, 1988, 36 days after receiving the submission on August 29, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K883680 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 29, 1988 |
| Decision Date | October 04, 1988 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LGX — Table, Examination, Medical, Powered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4960 |