The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Seednet Gold With Renal Kit, Model Fprpr 3021, (renal Kit), Fprch 2024 (seednetgold).
| Device ID | K042667 |
| 510k Number | K042667 |
| Device Name: | SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD) |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | GALIL MEDICAL LTD. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahn |
| Correspondent | Jonathan S Kahn GALIL MEDICAL LTD. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-29 |
| Decision Date | 2004-10-14 |
| Summary: | summary |