The following data is part of a premarket notification filed by Widran Urological Group, Ltd. with the FDA for Solid State Continuous Flow Control Model W/k101.
| Device ID | K861460 |
| 510k Number | K861460 |
| Device Name: | SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101 |
| Classification | Antisera, If, Toxoplasma Gondii |
| Applicant | WIDRAN UROLOGICAL GROUP, LTD. 111 NORTH WABASH AVE. Chicago, IL 60602 |
| Contact | Jerrold Widran |
| Correspondent | Jerrold Widran WIDRAN UROLOGICAL GROUP, LTD. 111 NORTH WABASH AVE. Chicago, IL 60602 |
| Product Code | LJK |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-18 |
| Decision Date | 1986-05-02 |