The following data is part of a premarket notification filed by Dacomed Corp. with the FDA for Omni Phase Penile Prosthesis.
| Device ID | K850019 |
| 510k Number | K850019 |
| Device Name: | OMNI PHASE PENILE PROSTHESIS |
| Classification | Prosthesis, Penile |
| Applicant | DACOMED CORP. 1701 E. 79TH ST., STE. 17 Minneapolis, MN 55425 |
| Contact | Frank B Freedman |
| Correspondent | Frank B Freedman DACOMED CORP. 1701 E. 79TH ST., STE. 17 Minneapolis, MN 55425 |
| Product Code | FAE |
| CFR Regulation Number | 876.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-03 |
| Decision Date | 1985-04-09 |