The following data is part of a premarket notification filed by Csa Medical, Inc. with the FDA for Trufreeze System.
| Device ID | K171626 |
| 510k Number | K171626 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-02 |
| Decision Date | 2017-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995199330 | K171626 | 000 |
| 10724995199323 | K171626 | 000 |
| 10724995199286 | K171626 | 000 |
| 10724995199224 | K171626 | 000 |
| 10724995199217 | K171626 | 000 |
| 10724995199200 | K171626 | 000 |
| 00724995199296 | K171626 | 000 |
| 00724995199302 | K171626 | 000 |