510(k) K042564
K042564 is an FDA 510(k) premarket notification submitted by Fama Holdings International Corp for the device "HEMOR-RITE CRYOTHERAPHY". The FDA issued a decision of Substantially Equivalent on Sep 30, 2005. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 30, 2005
- Date Received
- Sep 21, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Thermal, Hemorrhoids
- Device Class
- Class U
- Review Panel
- GU
- Submission Type
- 510(k)