The following data is part of a premarket notification filed by Laborie Medical Tech Corp. with the FDA for Cart, Mode Number Uds-cart.
| Device ID | K950016 |
| 510k Number | K950016 |
| Device Name: | CART, MODE NUMBER UDS-CART |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | LABORIE MEDICAL TECH CORP. 6415 NORTHWEST DR. UNIT #11 Mississauga,ontario, CA L4v 1x1 |
| Contact | Fred Buffa |
| Correspondent | Fred Buffa LABORIE MEDICAL TECH CORP. 6415 NORTHWEST DR. UNIT #11 Mississauga,ontario, CA L4v 1x1 |
| Product Code | FEN |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-03 |
| Decision Date | 1995-03-30 |