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 |