The following data is part of a premarket notification filed by Laborie Medical Tech Corp. with the FDA for Urostym Biofeedback And Stimulation Probes.
| Device ID | K990041 |
| 510k Number | K990041 |
| Device Name: | UROSTYM BIOFEEDBACK AND STIMULATION PROBES |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | LABORIE MEDICAL TECH CORP. 310 HURRICANE LN. #2 Williston, VT 05495 |
| Contact | Dale Coleman |
| Correspondent | Dale Coleman LABORIE MEDICAL TECH CORP. 310 HURRICANE LN. #2 Williston, VT 05495 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-06 |
| Decision Date | 1999-08-05 |