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FDA 510(k) Application Details - K131781
Device Classification Name
Cannula, Manipulator/Injector, Uterine
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LKF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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