FDA 510(k) Application Details - K974801

Device Classification Name Elevator, Uterine

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510(K) Number K974801
Device Name Elevator, Uterine
Applicant CONKIN SURGICAL INSTRUMENTS LTD.
P.O.BOX 6707, STATION "A"
TORONTA, ONTARIO M5W 1X5 CA
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Contact KINA MARKOFF
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Regulation Number 884.4530

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Classification Product Code HDP
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Date Received 12/22/1997
Decision Date 07/09/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K974801


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