510(k) K170810
K170810 is an FDA 510(k) premarket notification submitted by Cryofos Medical GmbH for the device "CRYOFOS". The FDA issued a decision of Substantially Equivalent on Sep 27, 2017. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 27, 2017
- Date Received
- Mar 17, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Cryosurgical, Accessories
- Device Class
- Class II
- Regulation Number
- 878.4350
- Review Panel
- SU
- Submission Type
- 510(k)