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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 K152641
Device Name Pi Drive Plus Motor, Extender
Applicant
STRYKER CORPORATION
400 E. MILHAM AVENUE
KALAMAZOO,  MI  49001
Applicant Contact DEVAL PATEL
Correspondent
STRYKER CORPORATION
4100 E. MILHAM AVENUE
KALAMAZOO,  MI  49001
Correspondent Contact JULIA HELGESON
Regulation Number874.4250
Classification Product Code
ERL  
Date Received09/15/2015
Decision Date 11/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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