The following data is part of a premarket notification filed by Pos-t-vac, Inc. with the FDA for Rejoyn Constriction Ring Kit, Pos-t-vac B-100 Ring Kit, Pos-t-vac B-25 Ring Kit And Pos-t-vac B-10 Ring Kit.
| Device ID | K981180 |
| 510k Number | K981180 |
| Device Name: | REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KIT |
| Classification | Device, External Penile Rigidity |
| Applicant | POS-T-VAC, INC. 1455 PENNSYLVANIA AVE. N.W. Washington, DC 20004 |
| Contact | Mark A Heller |
| Correspondent | Mark A Heller POS-T-VAC, INC. 1455 PENNSYLVANIA AVE. N.W. Washington, DC 20004 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-01 |
| Decision Date | 1998-08-28 |