The following data is part of a premarket notification filed by Charles L. Rose And Co., Inc. with the FDA for Ktp/532 & Ktp/yag Surgical Lasers.
| Device ID | K913244 |
| 510k Number | K913244 |
| Device Name: | KTP/532 & KTP/YAG SURGICAL LASERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CHARLES L. ROSE AND CO., INC. 3052 ORCHARD DR. San Jose, CA 95134 |
| Contact | Donna Page |
| Correspondent | Donna Page CHARLES L. ROSE AND CO., INC. 3052 ORCHARD DR. San Jose, CA 95134 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-22 |
| Decision Date | 1992-07-28 |