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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 K190172
Device Name Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
Applicant
Stryker
4100 E. Milham Ave
Kalamazoo,  MI  49001
Applicant Contact David Colao
Correspondent
Stryker
4100 E. Milham Ave
Kalamazoo,  MI  49001
Correspondent Contact David Colao
Regulation Number882.4310
Classification Product Code
HBE  
Subsequent Product Codes
DZI   ERL   HBB  
Date Received02/01/2019
Decision Date 06/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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