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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 K191049
Device Name Stryker MIS and Footed Attachments
Applicant
Stryker Corporation
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact Paminder Khurmi
Correspondent
Stryker Corporation
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact Paminder Khurmi
Regulation Number882.4310
Classification Product Code
HBE  
Subsequent Product Code
ERL  
Date Received04/19/2019
Decision Date 06/18/2019
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
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