510(k) K973590
K973590 is an FDA 510(k) premarket notification submitted by A.Stein - Regulatory Affairs Consulting for the device "HEMORRELIEF DEVICE". The FDA issued a decision of Substantially Equivalent on Feb 5, 1998. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device. A.Stein - Regulatory Affairs Consulting has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 5, 1998
- Date Received
- Sep 22, 1997
- 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)