The following data is part of a premarket notification filed by American Medical Corp. with the FDA for Ams 700 Ultrex(tm) Preconnected Penile Prosthesis.
| Device ID | K910214 |
| 510k Number | K910214 |
| Device Name: | AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS |
| Classification | Prosthesis, Penile |
| Applicant | AMERICAN MEDICAL CORP. 11001 BREN RD. EAST Minnetonka, MN 55343 |
| Contact | Quinlan Smith |
| Correspondent | Quinlan Smith AMERICAN MEDICAL CORP. 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 | 1991-01-17 |
| Decision Date | 1991-04-25 |