K040300 is an FDA 510(k) clearance for the STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE). This device is classified as a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II - Special Controls, product code ERL).
Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on March 3, 2004, 23 days after receiving the submission on February 9, 2004.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4250.
| 510(k) Number | K040300 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2004 |
| Decision Date | March 03, 2004 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ERL — Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4250 |