The following data is part of a premarket notification filed by Dacomed Corp. with the FDA for Eska Jonas Silicon-silver Penile.
| Device ID | K834504 |
| 510k Number | K834504 |
| Device Name: | ESKA JONAS SILICON-SILVER PENILE |
| Classification | Prosthesis, Penile |
| Applicant | DACOMED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FAE |
| CFR Regulation Number | 876.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-21 |
| Decision Date | 1984-02-04 |