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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ear, Nose, And Throat Stereotaxic Instrument
510(k) Number K202609
Device Name Instrument Clamps Electromagnetic
Applicant
Stryker Corporation
Boetzinger Strasse 41
Freiburg,  DE D-79111
Applicant Contact Maya Schiel
Correspondent
Stryker Corporation
Boetzinger Strasse 41
Freiburg,  DE D-79111
Correspondent Contact Maya Schiel
Regulation Number882.4560
Classification Product Code
PGW  
Date Received09/09/2020
Decision Date 10/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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