The following data is part of a premarket notification filed by Stryker Ireland Ltd., Instruments Division with the FDA for Stryker Essx Microdebrider System.
| Device ID | K073633 |
| 510k Number | K073633 |
| Device Name: | STRYKER ESSX MICRODEBRIDER SYSTEM |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | STRYKER IRELAND LTD., INSTRUMENTS DIVISION CARRIGTWOHILL BUSINESS & TECHNOLOGY PARK Carrigtwohill, Co.cork, IE |
| Contact | Colette O'connor |
| Correspondent | Colette O'connor STRYKER IRELAND LTD., INSTRUMENTS DIVISION CARRIGTWOHILL BUSINESS & TECHNOLOGY PARK Carrigtwohill, Co.cork, IE |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-08-26 |
| Summary: | summary |