The following data is part of a premarket notification filed by Vivus, Inc. with the FDA for Actis (venous Flow Controller).
| Device ID | K962915 |
| 510k Number | K962915 |
| Device Name: | ACTIS (VENOUS FLOW CONTROLLER) |
| Classification | Device, External Penile Rigidity |
| Applicant | VIVUS, INC. 545 MIDDLEFIELD RD., SUITE 200 Menlo Park, CA 94025 |
| Contact | Neil Gesundheit, M.d. |
| Correspondent | Neil Gesundheit, M.d. VIVUS, INC. 545 MIDDLEFIELD RD., SUITE 200 Menlo Park, CA 94025 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-26 |
| Decision Date | 1996-12-10 |
| Summary: | summary |