The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Ams Optilume(tm) Prostate Balloon Dilator.
| Device ID | K900761 |
| 510k Number | K900761 |
| Device Name: | AMS OPTILUME(TM) PROSTATE BALLOON DILATOR |
| Classification | Dilator, Urethral |
| 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 | KOE |
| CFR Regulation Number | 876.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-16 |
| Decision Date | 1990-05-17 |