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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elevator, Uterine
510(k) Number K974801
Device Name SINGLE CHANNEL BALLOON CANNULA
Applicant
CONKIN SURGICAL INSTRUMENTS LTD.
P.O.BOX 6707, STATION "A"
TORONTA, ONTARIO,  CA M5W 1X5
Applicant Contact KINA MARKOFF
Correspondent
CONKIN SURGICAL INSTRUMENTS LTD.
P.O.BOX 6707, STATION "A"
TORONTA, ONTARIO,  CA M5W 1X5
Correspondent Contact KINA MARKOFF
Regulation Number884.4530
Classification Product Code
HDP  
Date Received12/22/1997
Decision Date 07/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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