K880988 is an FDA 510(k) clearance for the PUDENDAL/LOCAL ANESTESIA BLOCK TRAY. This device is classified as a Set, Anesthesia, Obstetric (Class II - Special Controls, product code KNE).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on June 1, 1988, 85 days after receiving the submission on March 8, 1988.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5100.
| 510(k) Number | K880988 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1988 |
| Decision Date | June 01, 1988 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | KNE — Set, Anesthesia, Obstetric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5100 |