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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Manipulator/Injector, Uterine
510(k) Number K131781
Device Name CLEARVIEW TOTAL
Applicant
Clinical Innovations, LLC
747 W 4170 S
Murray,  UT  84123
Applicant Contact BRIAN MCROBERTS
Correspondent
Clinical Innovations, LLC
747 W 4170 S
Murray,  UT  84123
Correspondent Contact BRIAN MCROBERTS
Regulation Number884.4530
Classification Product Code
LKF  
Date Received06/17/2013
Decision Date 05/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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