The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Surgical Cutting Burs.
| Device ID | K943540 |
| 510k Number | K943540 |
| Device Name: | SURGICAL CUTTING BURS |
| Classification | Driver, Wire, And Bone Drill, Manual |
| Applicant | STRYKER CORP. 4100 E MILHAM AVE. Portage, MI 49002 -9704 |
| Contact | Tammy Lounds |
| Correspondent | Tammy Lounds STRYKER CORP. 4100 E MILHAM AVE. Portage, MI 49002 -9704 |
| Product Code | DZJ |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-22 |
| Decision Date | 1994-11-30 |