The following data is part of a premarket notification filed by Pos-t-vac, Inc. with the FDA for Boss 2000-3 Vacuum Erection Device.
| Device ID | K012670 |
| 510k Number | K012670 |
| Device Name: | BOSS 2000-3 VACUUM ERECTION DEVICE |
| Classification | Device, External Penile Rigidity |
| Applicant | POS-T-VAC, INC. 1701 NORTH 14TH AVE. P.O. BOX 1436 Dodge City, KS 67801 |
| Contact | Dennis L Bell |
| Correspondent | Dennis L Bell POS-T-VAC, INC. 1701 NORTH 14TH AVE. P.O. BOX 1436 Dodge City, KS 67801 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-13 |
| Decision Date | 2001-11-09 |