The following data is part of a premarket notification filed by Mission Pharmacal Co. with the FDA for Vacuum Erection Device (ved).
| Device ID | K901223 |
| 510k Number | K901223 |
| Device Name: | VACUUM ERECTION DEVICE (VED) |
| Classification | Device, External Penile Rigidity |
| Applicant | MISSION PHARMACAL CO. P.O. BOX 1676 San Antonio, TX 78296 |
| Contact | George Alexandrides |
| Correspondent | George Alexandrides MISSION PHARMACAL CO. P.O. BOX 1676 San Antonio, TX 78296 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-14 |
| Decision Date | 1990-05-04 |