The following data is part of a premarket notification filed by Laborie Medical Technologies, Ltd. with the FDA for U-tex.
| Device ID | K955810 |
| 510k Number | K955810 |
| Device Name: | U-TEX |
| Classification | Clamp, Penile |
| Applicant | LABORIE MEDICAL TECHNOLOGIES, LTD. 6415 NORTHWEST DR. UNIT 11 Mississauga (ontario), CA L4v 1x1 |
| Contact | Fred Buffa |
| Correspondent | Fred Buffa LABORIE MEDICAL TECHNOLOGIES, LTD. 6415 NORTHWEST DR. UNIT 11 Mississauga (ontario), CA L4v 1x1 |
| Product Code | FHA |
| CFR Regulation Number | 876.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-26 |
| Decision Date | 1996-01-24 |