The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Seednet System And Seednetgold System.
| Device ID | K031117 |
| 510k Number | K031117 |
| Device Name: | SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | GALIL MEDICAL LTD. YOKNEAM GATE, 1 TAVOR BLDG. Yokneam, IL 20692 |
| Contact | Roni Zvuloni |
| Correspondent | Roni Zvuloni GALIL MEDICAL LTD. YOKNEAM GATE, 1 TAVOR BLDG. Yokneam, IL 20692 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-08 |
| Decision Date | 2003-05-23 |
| Summary: | summary |