The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Seednet, Models Fp6t5, Fp5t5, Fp5t3.
| Device ID | K010991 |
| 510k Number | K010991 |
| Device Name: | SEEDNET, MODELS FP6T5, FP5T5, FP5T3 |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | GALIL MEDICAL LTD. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Johathan S Kahan |
| Correspondent | Johathan 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 | 2001-04-03 |
| Decision Date | 2001-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290104830525 | K010991 | 000 |
| 07290104830518 | K010991 | 000 |
| 07290104830068 | K010991 | 000 |