The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Seednet, Seednet Gold, Cryohit, Cryo Thera.
| Device ID | K060390 |
| 510k Number | K060390 |
| Device Name: | SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA |
| 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 | 2006-02-14 |
| Decision Date | 2006-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290104830983 | K060390 | 000 |
| 07290104830426 | K060390 | 000 |
| 07290104830303 | K060390 | 000 |
| 07290104830259 | K060390 | 000 |
| 07290104830211 | K060390 | 000 |
| 07290104830204 | K060390 | 000 |
| 07290104830105 | K060390 | 000 |
| 07290104830099 | K060390 | 000 |
| 07290104830075 | K060390 | 000 |