The following data is part of a premarket notification filed by Dacomed Corp. with the FDA for Dura Ii Penile Prosthesis.
| Device ID | K920420 |
| 510k Number | K920420 |
| Device Name: | DURA II PENILE PROSTHESIS |
| Classification | Prosthesis, Penile |
| Applicant | DACOMED CORP. 1701 E. 79TH ST., STE. 17 Minneapolis, MN 55425 |
| Contact | Mary M Wilen |
| Correspondent | Mary M Wilen 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 | 1992-01-31 |
| Decision Date | 1992-04-16 |