UROSTYM
Stimulator, Electrical, Non-implantable, For Incontinence
LABORIE MEDICAL TECHNOLOGIES, LTD.
The following data is part of a premarket notification filed by Laborie Medical Technologies, Ltd. with the FDA for Urostym.
Pre-market Notification Details
| Device ID | K962009 |
| 510k Number | K962009 |
| Device Name: | UROSTYM |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | LABORIE MEDICAL TECHNOLOGIES, LTD. 7 GREEN TREE DR. South Burlington, VT 05403 |
| Contact | Mike Barre |
| Correspondent | Mike Barre LABORIE MEDICAL TECHNOLOGIES, LTD. 7 GREEN TREE DR. South Burlington, VT 05403 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-22 |
| Decision Date | 1997-05-20 |
Trademark Results [UROSTYM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UROSTYM 78734119 3285680 Live/Registered |
LABORIE MEDICAL TECHNOLOGIES CANADA ULC 2005-10-16 |
 UROSTYM 74254713 1839906 Dead/Cancelled |
LABORIE MEDICAL TECHNOLOGIES, INC. 1992-03-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.