The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Consolidated Operating Room Equipment (core).
| Device ID | K040300 |
| 510k Number | K040300 |
| Device Name: | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| 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 | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-09 |
| Decision Date | 2004-03-03 |
| Summary: | summary |