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 |