The following data is part of a premarket notification filed by Vivus, Inc. with the FDA for Actis Adjustable Constriction Loop.
| Device ID | K003115 |
| 510k Number | K003115 |
| Device Name: | ACTIS ADJUSTABLE CONSTRICTION LOOP |
| Classification | Device, External Penile Rigidity |
| Applicant | VIVUS, INC. 1172 CASTRO ST. Mountain View, CA 94040 |
| Contact | Carol D Karp |
| Correspondent | Carol D Karp VIVUS, INC. 1172 CASTRO ST. Mountain View, CA 94040 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-02 |
| Decision Date | 2000-12-19 |