The following data is part of a premarket notification filed by Encore, Inc. with the FDA for Vtu-e Vacuum Erection System.
| Device ID | K974470 |
| 510k Number | K974470 |
| Device Name: | VTU-E VACUUM ERECTION SYSTEM |
| Classification | Device, External Penile Rigidity |
| Applicant | ENCORE, INC. 1900 K ST. , N.W. Washington, DC 20005 |
| Contact | Donald R Stone |
| Correspondent | Donald R Stone ENCORE, INC. 1900 K ST. , N.W. Washington, DC 20005 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-26 |
| Decision Date | 1998-01-09 |
| Summary: | summary |