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 |