The following data is part of a premarket notification filed by American Cystocope Makers, Inc. with the FDA for Sterile Fluid Producing Unit #ep550.
| Device ID | K832040 |
| 510k Number | K832040 |
| Device Name: | STERILE FLUID PRODUCING UNIT #EP550 |
| Classification | System, Irrigation, Urological |
| Applicant | AMERICAN CYSTOCOPE MAKERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-24 |
| Decision Date | 1983-09-29 |