The following data is part of a premarket notification filed by Valley Forge Scientific Corp. with the FDA for Malis Irrigation System.
| Device ID | K854413 |
| 510k Number | K854413 |
| Device Name: | MALIS IRRIGATION SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEY FORGE SCIENTIFIC CORP. P.O. BOX 925 Valley Forge, PA 19482 |
| Contact | Jerry L Malis |
| Correspondent | Jerry L Malis VALLEY FORGE SCIENTIFIC CORP. P.O. BOX 925 Valley Forge, PA 19482 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-04 |
| Decision Date | 1985-12-02 |