The following data is part of a premarket notification filed by Charles L. Rose And Co., Inc. with the FDA for Model Glase 210 Holmium Laser System.
| Device ID | K904248 |
| 510k Number | K904248 |
| Device Name: | MODEL GLASE 210 HOLMIUM LASER SYSTEM |
| Classification | Source, Abortion Unit, Vacuum |
| Applicant | CHARLES L. ROSE AND CO., INC. 1963 ROCK STREET, SUITE 17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose CHARLES L. ROSE AND CO., INC. 1963 ROCK STREET, SUITE 17 Mountain View, CA 94043 |
| Product Code | HGF |
| CFR Regulation Number | 884.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-17 |
| Decision Date | 1990-12-14 |