The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Seednet, Model Ep6t5, Ep5e5.
| Device ID | K003065 |
| 510k Number | K003065 |
| Device Name: | SEEDNET, MODEL EP6T5, EP5E5 |
| 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 | 2000-10-02 |
| Decision Date | 2000-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290104830310 | K003065 | 000 |
| 07290104830181 | K003065 | 000 |