The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Consolidated Operating Room Equipment (core) 2 Console.
| Device ID | K171840 |
| 510k Number | K171840 |
| Device Name: | Stryker Consolidated Operating Room Equipment (CORE) 2 Console |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | Stryker Corporation 4100 E. Milham Ave. Kalamazoo, MI 49001 |
| Contact | Nicholas Werner |
| Correspondent | Nicholas Werner 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 | 2017-06-20 |
| Decision Date | 2017-09-15 |
| Summary: | summary |