510(k) K921189
K921189 is an FDA 510(k) premarket notification submitted by Zewa AG for the device "THERMA-H". The FDA issued a decision of Substantially Equivalent on Aug 31, 1992. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device. Zewa AG has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 31, 1992
- Date Received
- Mar 3, 1992
- 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)