The following data is part of a premarket notification filed by Mckenna & Cuneo with the FDA for Vtu-1 Vacuum Erection System.
| Device ID | K971257 |
| 510k Number | K971257 |
| Device Name: | VTU-1 VACUUM ERECTION SYSTEM |
| Classification | Device, External Penile Rigidity |
| Applicant | MCKENNA & CUNEO 1900 K STREET, N.W. Washington, DC 20006 -1108 |
| Contact | Donald R Stone |
| Correspondent | Donald R Stone MCKENNA & CUNEO 1900 K STREET, N.W. Washington, DC 20006 -1108 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-04 |
| Decision Date | 1997-10-03 |
| Summary: | summary |