510(k) K072690
K072690 is an FDA 510(k) premarket notification submitted by Hemaway, LLC for the device "HEMAWAY SEAT". The FDA issued a decision of Substantially Equivalent on December 7, 2007. The device falls under product code LRL (Cushion, Hemorrhoid), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 2007
- Date Received
- September 24, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cushion, Hemorrhoid
- Device Class
- Class U
- Regulation Number
- Review Panel
- GU
- Submission Type