The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Liberty Rectal Pelvic Floor Exerciser.
Device ID | K964526 |
510k Number | K964526 |
Device Name: | LIBERTY RECTAL PELVIC FLOOR EXERCISER |
Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
Applicant | UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
Contact | John W Smith |
Correspondent | John W Smith 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 | 1996-11-12 |
Decision Date | 1997-02-10 |
Summary: | summary |