The following data is part of a premarket notification filed by Applied Urology, Inc. with the FDA for Working Channel Valve.
| Device ID | K900781 |
| 510k Number | K900781 |
| Device Name: | WORKING CHANNEL VALVE |
| Classification | Adaptor, Bulbs, Miscellaneous, For Endoscope |
| Applicant | APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills, CA 92653 |
| Contact | Nabil Hilal |
| Correspondent | Nabil Hilal APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills, CA 92653 |
| Product Code | FFY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-20 |
| Decision Date | 1990-04-25 |