FDA 510(k) Application Details - K041062

Device Classification Name Cannula, Manipulator/Injector, Uterine

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510(K) Number K041062
Device Name Cannula, Manipulator/Injector, Uterine
Applicant COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
SPENCER, IN 47460 US
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Contact CINDY RUMPLE
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Regulation Number 000.0000

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Classification Product Code LKF
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Date Received 04/23/2004
Decision Date 10/01/2004
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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