K823234 is an FDA 510(k) clearance for the RADIATION STERILIZATION OF SURG. GLOVES..
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Walker, US). The FDA issued a Cleared decision on April 17, 1984, 533 days after receiving the submission on November 1, 1982.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K823234 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1982 |
| Decision Date | April 17, 1984 |
| Days to Decision | 533 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | — |
| Device Class | — |