K832398 is an FDA 510(k) clearance for the DYNACOR CONNECTING TUBING. This device is classified as a Tube, Aspirating, Flexible, Connecting (Class II - Special Controls, product code BYY).
Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 24, 1983, 35 days after receiving the submission on July 20, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K832398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 1983 |
| Decision Date | August 24, 1983 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | BYY — Tube, Aspirating, Flexible, Connecting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |