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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 K193118
Device Name TGS Guidewire and updated Scopis Software
Applicant
Stryker ENT
3600 Holly Lane North, Suite 40
Plymouth,  MN  55447
Applicant Contact Bruce Backlund
Correspondent
Stryker ENT
3600 Holly Lane North, Suite 40
Plymouth,  MN  55447
Correspondent Contact Bruce Backlund
Regulation Number882.4560
Classification Product Code
PGW  
Date Received11/12/2019
Decision Date 02/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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