The following data is part of a premarket notification filed by American Healthcare Corp. with the FDA for Irrigation Tray W/ Piston Syringe & Sterile Water.
| Device ID | K923938 |
| 510k Number | K923938 |
| Device Name: | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER |
| Classification | Tray, Irrigation, Sterile |
| Applicant | AMERICAN HEALTHCARE CORP. ONE AMERICAN HEALTHCARE PLAZA 3611 KENNEDY ROAD South Plainfield, NJ 07080 |
| Contact | Ralph S Jarrett |
| Correspondent | Ralph S Jarrett AMERICAN HEALTHCARE CORP. ONE AMERICAN HEALTHCARE PLAZA 3611 KENNEDY ROAD South Plainfield, NJ 07080 |
| Product Code | EYN |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-05 |
| Decision Date | 1993-06-17 |