The following data is part of a premarket notification filed by Charles I. Rose & Co., Inc. with the FDA for Autoderm Scanner Control Console.
| Device ID | K904266 |
| 510k Number | K904266 |
| Device Name: | AUTODERM SCANNER CONTROL CONSOLE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CHARLES I. ROSE & CO., INC. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Contact | Charles I Rose |
| Correspondent | Charles I Rose CHARLES I. ROSE & CO., INC. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-18 |
| Decision Date | 1991-02-19 |