The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Model 4900 Nd:yag Laser For Endometrial Ablation.
| Device ID | K880173 |
| 510k Number | K880173 |
| Device Name: | MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION |
| Classification | Laser, Surgical, Gynecologic |
| 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 | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-15 |
| Decision Date | 1988-03-24 |