The following data is part of a premarket notification filed by Menlo Care, Inc. with the FDA for Menlo Care Aquastent Set.
| Device ID | K923394 |
| 510k Number | K923394 |
| Device Name: | MENLO CARE AQUASTENT SET |
| Classification | Stent, Ureteral |
| Applicant | MENLO CARE, INC. 1350 WILLOW RD. Menlo Park, CA 94025 -1516 |
| Contact | Bob Bley |
| Correspondent | Bob Bley MENLO CARE, INC. 1350 WILLOW RD. Menlo Park, CA 94025 -1516 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-10 |
| Decision Date | 1993-11-16 |