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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 K080052
Device Name STRYKER ESSX WITH NAVIGATION MOUNT
Applicant
STRYKER CORP.
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact VALERIE FRANCK
Correspondent
STRYKER CORP.
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact VALERIE FRANCK
Regulation Number874.4250
Classification Product Code
ERL  
Date Received01/08/2008
Decision Date 10/02/2008
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
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