The following data is part of a premarket notification filed by Csa Medical, Inc. with the FDA for Trufreeze System.
| Device ID | K162695 |
| 510k Number | K162695 |
| Device Name: | TruFreeze System |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CSA MEDICAL, INC. 91 HARTWELL AVENUE Lexington, MA 02421 |
| Contact | Sherrie Coval-goldsmith |
| Correspondent | Sherrie Coval-goldsmith CSA MEDICAL, INC. 91 HARTWELL AVENUE Lexington, MA 02421 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-27 |
| Decision Date | 2016-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857068006068 | K162695 | 000 |
| 00857068006051 | K162695 | 000 |
| 10857068006058 | K162695 | 000 |