Device Classification Name |
drill, surgical, ent (electric or pneumatic) including handpiece
|
510(k) Number |
K073633 |
Device Name |
STRYKER ESSX MICRODEBRIDER SYSTEM |
Applicant |
STRYKER IRELAND LTD., INSTRUMENTS DIVISION |
CARRIGTWOHILL BUSINESS & |
TECHNOLOGY PARK |
CARRIGTWOHILL, CO.CORK,
IE
|
|
Applicant Contact |
COLETTE O'CONNOR |
Correspondent |
STRYKER IRELAND LTD., INSTRUMENTS DIVISION |
CARRIGTWOHILL BUSINESS & |
TECHNOLOGY PARK |
CARRIGTWOHILL, CO.CORK,
IE
|
|
Correspondent Contact |
COLETTE O'CONNOR |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 12/26/2007 |
Decision Date | 08/26/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|