The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Styker Consolidated Operating Room Equipment (core) System.
| Device ID | K112593 |
| 510k Number | K112593 |
| Device Name: | STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo, MI 49001 |
| Contact | Michelle Jump |
| Correspondent | Michelle Jump STRYKER CORPORATION 4100 E. 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 | 2011-09-07 |
| Decision Date | 2012-05-01 |
| Summary: | summary |