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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Neurological
510(k) Number K200925
Device Name Clarus Peel-Away Introducer Sheath
Applicant
Clarus Medical, LLC
13355 10th Ave. N Suite 110
Plymouth,  MN  55441
Applicant Contact Mark F. Brown
Correspondent
Clarus Medical, LLC
13355 10th Ave. N Suite 110
Plymouth,  MN  55441
Correspondent Contact Mark F. Brown
Regulation Number882.1480
Classification Product Code
GWG  
Date Received04/07/2020
Decision Date 03/18/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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