The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Cooper Laser Sonics Cusa Model 200.
| Device ID | K853143 |
| 510k Number | K853143 |
| Device Name: | COOPER LASER SONICS CUSA MODEL 200 |
| Classification | Device, Neurosurgical Fragmentation And Aspiration |
| 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 | LBK |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-29 |
| Decision Date | 1985-10-16 |