The following data is part of a premarket notification filed by Laborie Medical Technologies, Corp with the FDA for Laborie Urodynamic System With Tetra Accessory.
| Device ID | K073552 |
| 510k Number | K073552 |
| Device Name: | LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | LABORIE MEDICAL TECHNOLOGIES, CORP 400 AVE D, STE 10 Williston, VT 05495 |
| Contact | Barbara Mornet |
| Correspondent | Barbara Mornet LABORIE MEDICAL TECHNOLOGIES, CORP 400 AVE D, STE 10 Williston, VT 05495 |
| Product Code | FEN |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-18 |
| Decision Date | 2008-03-05 |
| Summary: | summary |