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 | K983245 |
| 510k Number | K983245 |
| 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 | Ed Stewart Jr |
| Correspondent | Ed Stewart Jr 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 | 1998-09-16 |
| Decision Date | 1998-11-02 |