The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Ams Malleable Or Jonas Silicone-silver.
| Device ID | K792724 |
| 510k Number | K792724 |
| Device Name: | AMS MALLEABLE OR JONAS SILICONE-SILVER |
| Classification | Prosthesis, Penile |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 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 | 1979-12-31 |
| Decision Date | 1980-09-09 |