K971307 is an FDA 510(k) clearance for the AMSCO SURGICAL TABLE. This device is classified as a Table, Operating-room, Ac-powered (Class I - General Controls, product code FQO).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on June 27, 1997, 80 days after receiving the submission on April 8, 1997.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K971307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 1997 |
| Decision Date | June 27, 1997 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FQO — Table, Operating-room, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4960 |