K896557 is an FDA 510(k) clearance for the YANKAUER SUCTION TUBE-FLEXIBLE TYPE. This device is classified as a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II - Special Controls, product code GCX).
Submitted by Westmark, Sterile Packing Systems, Inc. (Sps) (Grand Rapids, US). The FDA issued a Cleared decision on February 6, 1990, 81 days after receiving the submission on November 17, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K896557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 1989 |
| Decision Date | February 06, 1990 |
| Days to Decision | 81 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 |