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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number874.4250
Classification Product Code
ERL  
Date Received12/26/2007
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
Predetermined Change
Control Plan Authorized		 No
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