The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Ultralite Urosystem, Models Gu-1 & Gu-2.
| Device ID | K790519 |
| 510k Number | K790519 |
| Device Name: | ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2 |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-16 |
| Decision Date | 1979-05-14 |