The following data is part of a premarket notification filed by Komet Medical with the FDA for Xk-95 High Speed Motor Drill System.
| Device ID | K984035 |
| 510k Number | K984035 |
| Device Name: | XK-95 HIGH SPEED MOTOR DRILL SYSTEM |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | KOMET MEDICAL 1679 KELLOGG SPRINGS DR. Atlanta, GA 30338 |
| Contact | Courtney S Paradice |
| Correspondent | Courtney S Paradice KOMET MEDICAL 1679 KELLOGG SPRINGS DR. Atlanta, GA 30338 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-12 |
| Decision Date | 1999-06-03 |