The following data is part of a premarket notification filed by Valley Forge Scientific Corp. with the FDA for Malis Irrigation Module 1000.
| Device ID | K033499 |
| 510k Number | K033499 |
| Device Name: | MALIS IRRIGATION MODULE 1000 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEY FORGE SCIENTIFIC CORP. 136 GREEN TREE RD., STE. 100 PO BOX 1179 Oaks, PA 19456 |
| Contact | Jerry L Malis |
| Correspondent | Jerry L Malis VALLEY FORGE SCIENTIFIC CORP. 136 GREEN TREE RD., STE. 100 PO BOX 1179 Oaks, PA 19456 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-05 |
| Decision Date | 2003-11-28 |
| Summary: | summary |