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FDA 510(k) Application Details - K974801
Device Classification Name
Elevator, Uterine
More FDA Info for this Device
510(K) Number
K974801
Device Name
Elevator, Uterine
Applicant
CONKIN SURGICAL INSTRUMENTS LTD.
P.O.BOX 6707, STATION "A"
TORONTA, ONTARIO M5W 1X5 CA
Other 510(k) Applications for this Company
Contact
KINA MARKOFF
Other 510(k) Applications for this Contact
Regulation Number
884.4530
More FDA Info for this Regulation Number
Classification Product Code
HDP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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