The following data is part of a premarket notification filed by Cryocath Technologies, Inc. with the FDA for Surgifrost 10 Cm Cryosurgical Device Plus Frostbyte Clamp And Cryosurgical Console.
| Device ID | K040690 |
| 510k Number | K040690 |
| Device Name: | SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | CRYOCATH TECHNOLOGIES, INC. 16771 CHEMIN STE. MARIE Kirkland, Quebec, CA H9h 5h3 |
| Contact | Flor Del Pilar Arana |
| Correspondent | Flor Del Pilar Arana CRYOCATH TECHNOLOGIES, INC. 16771 CHEMIN STE. MARIE Kirkland, Quebec, CA H9h 5h3 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-16 |
| Decision Date | 2004-04-29 |
| Summary: | summary |