The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Cryo-hit Ii, Models Ep3t3, Ep5t2, Ep5t5, Ep7t5, Ep8t5.
| Device ID | K991517 |
| 510k Number | K991517 |
| Device Name: | CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 |
| 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 | 1999-04-30 |
| Decision Date | 1999-07-27 |
| Summary: | summary |