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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bur, ear, nose and throat
510(k) Number K161514
Device Name Precision Thin Reciprocating Blade, 0.010in.
Applicant
STRYKER CORPORATION
4100 E. MILHAM AVE
KALAMAZOO,  MI  49009
Applicant Contact Joanna McCarthy
Correspondent
STRYKER CORPORATION
4100 E. MILHAM AVE
KALAMAZOO,  MI  49009
Correspondent Contact Joanna McCarthy
Regulation Number874.4140
Classification Product Code
EQJ  
Date Received06/02/2016
Decision Date 01/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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