The following data is part of a premarket notification filed by Owen Mumford Usa, Inc. with the FDA for Rapport V.t.d..
| Device ID | K971443 |
| 510k Number | K971443 |
| Device Name: | RAPPORT V.T.D. |
| Classification | Device, External Penile Rigidity |
| Applicant | OWEN MUMFORD USA, INC. 849 PICKENS INDUSTRIAL DR. SUITE 14 Marietta, GA 30062 |
| Contact | Robert E Shaw |
| Correspondent | Robert E Shaw OWEN MUMFORD USA, INC. 849 PICKENS INDUSTRIAL DR. SUITE 14 Marietta, GA 30062 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-21 |
| Decision Date | 1997-09-26 |
| Summary: | summary |