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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 K193502
Device Name TGS Universal Headrest with Mounting Arm
Applicant
Stryker ENT
3600 Holly Lane North, Suite 40
Plymouth,  MN  55447
Applicant Contact Denise Thompson
Correspondent
Stryker ENT
3600 Holly Lane North, Suite 40
Plymouth,  MN  55447
Correspondent Contact Denise Thompson
Regulation Number882.4560
Classification Product Code
PGW  
Date Received12/18/2019
Decision Date 02/14/2020
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
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