K853479 is an FDA 510(k) clearance for the SKYTRON ELITE 300 SURGERY TABLE. This device is classified as a Table, Operating-room, Pneumatic (Class I - General Controls, product code FWW).
Submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on September 5, 1985, 16 days after receiving the submission on August 20, 1985.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K853479 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1985 |
| Decision Date | September 05, 1985 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FWW — Table, Operating-room, Pneumatic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4960 |