510(k) K193619
K193619 is an FDA 510(k) premarket notification submitted by Brymill Cryogenic Systems for the device "Cry-Ac®, Cry-Ac-3®, Cry-Baby". The FDA issued a decision of Substantially Equivalent on Mar 25, 2020. 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
- Mar 25, 2020
- Date Received
- Dec 26, 2019
- 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)