The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Ams Spectra Concealable Penile Prosthesis.
| Device ID | K082006 |
| 510k Number | K082006 |
| Device Name: | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS |
| Classification | Prosthesis, Penile |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | Stephanie George |
| Correspondent | Stephanie George AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST 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 | 2008-07-15 |
| Decision Date | 2008-10-20 |
| Summary: | summary |