The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Ams Malleable 600 And 600m Penile Prosthesis.
| Device ID | K912935 |
| 510k Number | K912935 |
| Device Name: | AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS |
| Classification | Prosthesis, Penile |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 11001 BREN RD. EAST Minnetonka, MN 55343 |
| Contact | Quinlan Smith |
| Correspondent | Quinlan Smith 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 | 1991-07-05 |
| Decision Date | 1992-03-18 |