The following data is part of a premarket notification filed by Stryker Ireland Ltd., Instruments Division with the FDA for Stryker Disposable Cranial Perforator Bit.
| Device ID | K082010 |
| 510k Number | K082010 |
| Device Name: | STRYKER DISPOSABLE CRANIAL PERFORATOR BIT |
| Classification | Drills, Burrs, Trephines & Accessories (compound, Powered) |
| 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 | HBF |
| CFR Regulation Number | 882.4305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-15 |
| Decision Date | 2008-12-29 |
| Summary: | summary |