The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Consolidated Operating Room Equipment (core) System.
| Device ID | K040369 |
| 510k Number | K040369 |
| Device Name: | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM |
| Classification | Driver, Wire, And Bone Drill, Manual |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Jean W Sheppard |
| Correspondent | Jean W Sheppard STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | DZJ |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-13 |
| Decision Date | 2004-04-01 |
| Summary: | summary |