510(k) K943250
K943250 is an FDA 510(k) premarket notification submitted by Utah Medical Products, Inc. for the device "LIBERTY". The FDA issued a decision of Substantially Equivalent on February 9, 1995. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Utah Medical Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 1995
- Date Received
- July 6, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Non-Implantable, For Incontinence
- Device Class
- Class II
- Regulation Number
- 876.5320
- Review Panel
- GU
- Submission Type