The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Seednet Family (seednet/seedgold System, Cryothera System, Cryo-hit System).
| Device ID | K051052 |
| 510k Number | K051052 |
| Device Name: | SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-25 |
| Decision Date | 2005-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290104830884 | K051052 | 000 |
| 07290104830327 | K051052 | 000 |
| 07290104830297 | K051052 | 000 |
| 07290104830280 | K051052 | 000 |
| 07290104830273 | K051052 | 000 |
| 07290104830266 | K051052 | 000 |
| 07290104830198 | K051052 | 000 |
| 07290104830082 | K051052 | 000 |