The following data is part of a premarket notification filed by Pos-t-vac, Inc. with the FDA for Pos-t-vac-avp-1000.
| Device ID | K941087 |
| 510k Number | K941087 |
| Device Name: | POS-T-VAC-AVP-1000 |
| Classification | Device, External Penile Rigidity |
| Applicant | POS-T-VAC, INC. 1701 NORTH 14TH AVE. P.O. BOX 1436 Dodge City, KS 67801 |
| Contact | Edward T Stewart, Sr. |
| Correspondent | Edward T Stewart, Sr. 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 | 1994-03-08 |
| Decision Date | 1994-07-25 |