K760586 is an FDA 510(k) clearance for the SUCTION KIT. This device is classified as a Catheter And Tip, Suction (Class II - Special Controls, product code JOL).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on November 12, 1976, 70 days after receiving the submission on September 3, 1976.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K760586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 1976 |
| Decision Date | November 12, 1976 |
| Days to Decision | 70 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 |