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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 K143320
Device Name Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
Applicant
Stryker Corp.
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact Brittney M. Larsen
Correspondent
Stryker Corp.
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact Brittney M. Larsen
Regulation Number882.4310
Classification Product Code
HBE  
Date Received11/19/2014
Decision Date 04/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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