510(k) K864470
K864470 is an FDA 510(k) premarket notification submitted by Health Aid Products for the device "HEMOREST(TM)". The FDA issued a decision of Substantially Equivalent on June 23, 1987. The device falls under product code LRL (Cushion, Hemorrhoid), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 1987
- Date Received
- November 12, 1986
- 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