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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
Predetermined Change
Control Plan Authorized		 No
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