The following data is part of a premarket notification filed by Cardiofocus, Inc. with the FDA for Surgical Lightstic, Models, 180 L, And 180 C.
| Device ID | K993834 |
| 510k Number | K993834 |
| Device Name: | SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CARDIOFOCUS, INC. 987 UNIVERSITY AVE. SUITE 14 Los Gatos, CA 95032 |
| Contact | William A Knape |
| Correspondent | William A Knape CARDIOFOCUS, INC. 987 UNIVERSITY AVE. SUITE 14 Los Gatos, CA 95032 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-12 |
| Decision Date | 2000-02-04 |
| Summary: | summary |