The following data is part of a premarket notification filed by Mission Pharmacal Comp with the FDA for Ved Valu- Vacuum Erection Device.
| Device ID | K980948 |
| 510k Number | K980948 |
| Device Name: | VED VALU- VACUUM ERECTION DEVICE |
| Classification | Device, External Penile Rigidity |
| Applicant | MISSION PHARMACAL COMP 24 CARPENTER RD. Chester, NY 10918 |
| Contact | Andrew I Sealfon |
| Correspondent | Andrew I Sealfon MISSION PHARMACAL COMP 24 CARPENTER RD. Chester, NY 10918 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-13 |
| Decision Date | 1998-06-25 |