The following data is part of a premarket notification filed by R. Laborie Surgical Ltd. with the FDA for Laborie Urodynamics Processor.
| Device ID | K920777 |
| 510k Number | K920777 |
| Device Name: | LABORIE URODYNAMICS PROCESSOR |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | R. LABORIE SURGICAL LTD. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Contact | James R Veale |
| Correspondent | James R Veale R. LABORIE SURGICAL LTD. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-20 |
| Decision Date | 1992-09-04 |