The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Cooper Lasersonics, 8000 Nd.yaglaser.
| Device ID | K841869 |
| 510k Number | K841869 |
| Device Name: | COOPER LASERSONICS, 8000 ND.YAGLASER |
| Classification | Laser For Gastro-urology Use |
| Applicant | COOPER LASERSONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-04 |
| Decision Date | 1984-08-08 |