K811192 is an FDA 510(k) clearance for the VAC-RITE SUNCTION COLLECTION. This device is classified as a Bottle, Collection, Vacuum (Class II - Special Controls, product code KDQ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on June 2, 1981, 33 days after receiving the submission on April 30, 1981.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K811192 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 1981 |
| Decision Date | June 02, 1981 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KDQ — Bottle, Collection, Vacuum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |