The following data is part of a premarket notification filed by Komet Medical with the FDA for Komet Xk-95 Perforator Motor (mi-102).
| Device ID | K991625 |
| 510k Number | K991625 |
| Device Name: | KOMET XK-95 PERFORATOR MOTOR (MI-102) |
| Classification | Motor, Drill, Pneumatic |
| Applicant | KOMET MEDICAL 2188 KNOLL DR. Savannah, GA 31419 |
| Contact | Courtney S Paradice |
| Correspondent | Courtney S Paradice KOMET MEDICAL 2188 KNOLL DR. Savannah, GA 31419 |
| Product Code | HBB |
| CFR Regulation Number | 882.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-11 |
| Decision Date | 1999-07-30 |