The following data is part of a premarket notification filed by Dacomed Corp. with the FDA for Silicone-silver Penile Prosthesis-esk.
| Device ID | K830667 |
| 510k Number | K830667 |
| Device Name: | SILICONE-SILVER PENILE PROSTHESIS-ESK |
| Classification | Prosthesis, Penis, Rigid Rod |
| Applicant | DACOMED CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FTQ |
| CFR Regulation Number | 876.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-04 |
| Decision Date | 1983-10-20 |