The following data is part of a premarket notification filed by Laborie Medical Technologies, Ltd. with the FDA for Tex-aid Blue.
| Device ID | K955856 |
| 510k Number | K955856 |
| Device Name: | TEX-AID BLUE |
| Classification | Device, External Penile Rigidity |
| Applicant | LABORIE MEDICAL TECHNOLOGIES, LTD. 6415 NORTHWEST DR. UNIT 10 Mississauga Ont. Canada, CA L4v1x1 |
| Contact | Fred Buffa |
| Correspondent | Fred Buffa LABORIE MEDICAL TECHNOLOGIES, LTD. 6415 NORTHWEST DR. UNIT 10 Mississauga Ont. Canada, CA L4v1x1 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-26 |
| Decision Date | 1996-02-16 |