The following data is part of a premarket notification filed by Komet Medical with the FDA for Surgical Bur.
| Device ID | K943758 |
| 510k Number | K943758 |
| Device Name: | SURGICAL BUR |
| Classification | Bur, Surgical, General & Plastic Surgery |
| Applicant | KOMET MEDICAL 800 KING GEORGE BLVD. Savannah, GA 31419 |
| Contact | Courtney S Paradice |
| Correspondent | Courtney S Paradice KOMET MEDICAL 800 KING GEORGE BLVD. Savannah, GA 31419 |
| Product Code | GFF |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-02 |
| Decision Date | 1994-08-22 |