The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Liberty Plus System(pfs-300)/vaginal Probe, Liberty Plus(pfs-044).
| Device ID | K970077 |
| 510k Number | K970077 |
| Device Name: | LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Contact | Nadeem Ahmed |
| Correspondent | Nadeem Ahmed 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 | 1997-01-09 |
| Decision Date | 1997-05-23 |
| Summary: | summary |