510(k) K852679
K852679 is an FDA 510(k) premarket notification submitted by J. & Jp., Inc. for the device "MULTIPLE(HEMORX) IF APPROVED BY TRADEMARK OFFICE". The FDA issued a decision of Substantially Equivalent on August 9, 1985. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device. J. & Jp., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 9, 1985
- Date Received
- June 25, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Thermal, Hemorrhoids
- Device Class
- Class U
- Regulation Number
- Review Panel
- GU
- Submission Type