K782027 is an FDA 510(k) clearance for the HYSTERECTOMY T DRAIN. This device is classified as a Catheter And Tip, Suction (Class II - Special Controls, product code JOL).
Submitted by Davol, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 20, 1978, 15 days after receiving the submission on December 5, 1978.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K782027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 1978 |
| Decision Date | December 20, 1978 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | JOL — Catheter And Tip, Suction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |