K790055 is an FDA 510(k) clearance for the TUBING, DYNACOR UNIVERSAL. This device is classified as a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II - Special Controls, product code GCX).
Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 22, 1979, 44 days after receiving the submission on January 9, 1979.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K790055 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1979 |
| Decision Date | February 22, 1979 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | GCX — Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |