The following data is part of a premarket notification filed by Cryofos Medical Gmbh with the FDA for Cryofos.
| Device ID | K170810 |
| 510k Number | K170810 |
| Device Name: | CRYOFOS |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CRYOFOS Medical Gmbh Lammstrasse 21 Karlsruhe, DE 76133 |
| Contact | Gerlinde Hornung-stehling |
| Correspondent | Nick Stocks Tenssource LLC 724 Bald Cypress Place Tampa, FL 33614 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-17 |
| Decision Date | 2017-09-27 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CRYOFOS 88514588 not registered Live/Pending |
Cryofos Medical GmbH 2019-07-15 |