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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K082038
Device Name CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V
Applicant
Clarus Medical, LLC
1000 Boone Ave. N.
Suite 300
Golden Valley,  MN  55427
Applicant Contact THOMAS BARTHEL
Correspondent
Clarus Medical, LLC
1000 Boone Ave. N.
Suite 300
Golden Valley,  MN  55427
Correspondent Contact THOMAS BARTHEL
Regulation Number868.5730
Classification Product Code
BTR  
Date Received07/17/2008
Decision Date 04/28/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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