The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Seednet System And Seednetgold System, Models Gp6t5, Gp5t5, Gp5t3, Hp5t5 & Hp5t3.
| Device ID | K021261 |
| 510k Number | K021261 |
| Device Name: | SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | GALIL MEDICAL LTD. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan GALIL MEDICAL LTD. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-19 |
| Decision Date | 2002-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290104830914 | K021261 | 000 |
| 07290104830020 | K021261 | 000 |