510(k) K862490
K862490 is an FDA 510(k) premarket notification submitted by J. & Jp., Inc. for the device "ANU-RX". The FDA issued a decision of Substantially Equivalent on Aug 18, 1986. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device. J. & Jp., Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 18, 1986
- Date Received
- Jul 1, 1986
- 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)