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 |