The following data is part of a premarket notification filed by Dacomed Corp. with the FDA for Modified Duraphase(tm) Implanted Penile Prosthesis.
| Device ID | K912344 |
| 510k Number | K912344 |
| Device Name: | MODIFIED DURAPHASE(TM) IMPLANTED 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 | 1991-05-28 |
| Decision Date | 1991-10-11 |