The following data is part of a premarket notification filed by Tri Hawk Corp. with the FDA for Tri Hawk Bur, Fg Bur.
| Device ID | K943273 |
| 510k Number | K943273 |
| Device Name: | TRI HAWK BUR, FG BUR |
| Classification | Bur, Dental |
| Applicant | TRI HAWK CORP. 849 S. BROADWAY, ROOM 811 Los Angeles, CA 90014 |
| Contact | Soledad Ashworth |
| Correspondent | Soledad Ashworth TRI HAWK CORP. 849 S. BROADWAY, ROOM 811 Los Angeles, CA 90014 |
| Product Code | EJL |
| CFR Regulation Number | 872.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-07 |
| Decision Date | 1994-08-01 |