FDA 510(k) Application Details - K071405

Device Classification Name Cannula, Manipulator/Injector, Uterine

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510(K) Number K071405
Device Name Cannula, Manipulator/Injector, Uterine
Applicant INTUITIVE SURGICAL, INC.
950 KIFER RD.
SUNNYVALE, CA 94086-5206 US
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Contact MICHAEL H YRAMATEGUI
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Regulation Number 000.0000

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Classification Product Code LKF
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Date Received 05/21/2007
Decision Date 10/09/2007
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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