The following data is part of a premarket notification filed by Ruja-med Medical Marketing with the FDA for Minnow Penile Implant Protector.
| Device ID | K904262 |
| 510k Number | K904262 |
| Device Name: | MINNOW PENILE IMPLANT PROTECTOR |
| Classification | Prosthesis, Penile |
| Applicant | RUJA-MED MEDICAL MARKETING 1401 UNIVERSITY DR. Coral Springs, FL 33071 |
| Contact | Paul K Berman |
| Correspondent | Paul K Berman RUJA-MED MEDICAL MARKETING 1401 UNIVERSITY DR. Coral Springs, FL 33071 |
| Product Code | FAE |
| CFR Regulation Number | 876.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-14 |
| Decision Date | 1990-12-13 |