LIBERTY

Stimulator, Electrical, Non-implantable, For Incontinence

UTAH MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Liberty.

Pre-market Notification Details

• Device ID: K943250
• 510k Number: K943250
• Device Name: LIBERTY
• Classification: Stimulator, Electrical, Non-implantable, For Incontinence
• Applicant: UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048
• Contact: Kevin L Cornwell
• Correspondent: Kevin L Cornwell; UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048
• Product Code: KPI
• CFR Regulation Number: 876.5320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-07-06
• Decision Date: 1995-02-09