The following data is part of a premarket notification filed by Csa Medical, Inc. with the FDA for Cryospray Ablation System, Model Cu 8407020500.
| Device ID | K070893 |
| 510k Number | K070893 |
| Device Name: | CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CSA MEDICAL, INC. 1101 E. 33RD STREET THIRD FLOOR - #A305 Baltimore, MD 21218 |
| Contact | Jennifer Cartledge |
| Correspondent | Jennifer Cartledge CSA MEDICAL, INC. 1101 E. 33RD STREET THIRD FLOOR - #A305 Baltimore, MD 21218 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-30 |
| Decision Date | 2007-05-01 |
| Summary: | summary |