The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Cryo-hit, Models Ep6t5, Fp5t5, Fp5t3, Ep2t2, Ep1t1, And Ep2t1.
| Device ID | K012497 |
| 510k Number | K012497 |
| Device Name: | CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 |
| 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 | 2001-08-03 |
| Decision Date | 2001-10-30 |
| Summary: | summary |