The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Cryo-hit,models Ed1to, Epiti, Ep2ti, Ep2t2, Ep3t3, Ep4t2, Ept3, Ep4t4,ep5t2, Ep5t3, Ep5t5, Ep6t5,ep7t3,ep7t5,ep8t3,and E.
| Device ID | K991272 |
| 510k Number | K991272 |
| Device Name: | CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | GALIL MEDICAL LTD. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein 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 | 1999-04-13 |
| Decision Date | 1999-07-12 |
| Summary: | summary |