The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for 700 Ultrex Penile Prosthesis 12mm Diameter.
| Device ID | K901482 |
| 510k Number | K901482 |
| Device Name: | 700 ULTREX PENILE PROSTHESIS 12MM DIAMETER |
| Classification | Prosthesis, Penile |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 11001 BREN RD. EAST Minnetonka, MN 55343 |
| Contact | Dennis Toussaint |
| Correspondent | Dennis Toussaint AMERICAN MEDICAL SYSTEMS, INC. 11001 BREN RD. EAST Minnetonka, MN 55343 |
| Product Code | FAE |
| CFR Regulation Number | 876.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-29 |
| Decision Date | 1990-06-27 |