The following data is part of a premarket notification filed by Cryocath Technologies, Inc. with the FDA for Surgifrost Xl Cryosurgical Device, Model 60sfxl; Cryosurgical Console, Model 65cs1.
| Device ID | K062140 |
| 510k Number | K062140 |
| Device Name: | SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1 |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | CRYOCATH TECHNOLOGIES, INC. 204 CLINTON ROAD Brookline, MA 02445 -5814 |
| Contact | Fred Milder |
| Correspondent | Fred Milder CRYOCATH TECHNOLOGIES, INC. 204 CLINTON ROAD Brookline, MA 02445 -5814 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-27 |
| Decision Date | 2006-08-24 |
| Summary: | summary |