The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Lasersonics Laser Cystoscope Model Fcy-6-35.
| Device ID | K860822 |
| 510k Number | K860822 |
| Device Name: | LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35 |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | COOPER LASERSONICS, INC. 3420 Central Expressway Santa Clara, CA 95051 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose COOPER LASERSONICS, INC. 3420 Central Expressway Santa Clara, CA 95051 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-04 |
| Decision Date | 1986-04-17 |