The following data is part of a premarket notification filed by Widran Urological Group, Ltd. with the FDA for Solid State Continuous Flow Control.
| Device ID | K822743 |
| 510k Number | K822743 |
| Device Name: | SOLID STATE CONTINUOUS FLOW CONTROL |
| Classification | System, Irrigation, Urological |
| Applicant | WIDRAN UROLOGICAL GROUP, LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-10 |
| Decision Date | 1982-09-24 |