The following data is part of a premarket notification filed by Applied Urology, Inc. with the FDA for Sureseal Endoscopic Valve.
| Device ID | K920030 |
| 510k Number | K920030 |
| Device Name: | SURESEAL ENDOSCOPIC VALVE |
| Classification | Endoscope Channel Accessory |
| Applicant | APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills, CA 92653 |
| Contact | Jo Stegwell |
| Correspondent | Jo Stegwell APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills, CA 92653 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-03 |
| Decision Date | 1992-03-18 |