K923938 is an FDA 510(k) clearance for the IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER. This device is classified as a Tray, Irrigation, Sterile (Class II - Special Controls, product code EYN).
Submitted by American Healthcare Corp. (South Plainfield, US). The FDA issued a Cleared decision on June 17, 1993, 316 days after receiving the submission on August 5, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K923938 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | August 05, 1992 |
| Decision Date | June 17, 1993 |
| Days to Decision | 316 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | EYN — Tray, Irrigation, Sterile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |