K832765 is an FDA 510(k) clearance for the FLEXI-TY. This device is classified as a Retractor (Class I - General Controls, product code GAD).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on January 27, 1984, 164 days after receiving the submission on August 16, 1983.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K832765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 1983 |
| Decision Date | January 27, 1984 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GAD — Retractor |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |