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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name drills, burrs, trephines & accessories (simple, powered)
510(k) Number K143399
Device Name Stryker Footed Attachments and Cutting Accessories
Applicant
STRYKER CORP.
4100 E. MILHAM AVE.
KALAMAZOO,  MI  49002
Applicant Contact VISHAL KANANI
Correspondent
STRYKER CORP.
4100 E. MILHAM AVE.
KALAMAZOO,  MI  49002
Correspondent Contact VISHAL KANANI
Regulation Number882.4310
Classification Product Code
HBE  
Date Received11/28/2014
Decision Date 05/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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