FDA 510(k) Application Details - K131781

Device Classification Name Cannula, Manipulator/Injector, Uterine

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510(K) Number K131781
Device Name Cannula, Manipulator/Injector, Uterine
Applicant CLINICAL INNOVATIONS, LLC
747 WEST 4170 SOUTH
MURRAY, UT 84123 US
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Contact BRIAN MCROBERTS
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Regulation Number 000.0000

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Classification Product Code LKF
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Date Received 06/17/2013
Decision Date 05/28/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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