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510(k) K974801

Device
SINGLE CHANNEL BALLOON CANNULA
Applicant
CONKIN SURGICAL INSTRUMENTS LTD.
510(k) number
K974801
Product code
HDP  
Decision
Substantially Equivalent (SESE)
Decision date
1998-07-09
Date received
1997-12-22
Regulation
884.4530
Classification name
Elevator, Uterine
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KINA MARKOFF
Address
P.O.Box 6707, Station "A" Toronta, Ontario CA M5W 1X5 M5W 1X5

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HDP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K974563COLPO CUP CVC-2000Clinical Innovations, Inc.1998-03-02
K882054HYSTERO KITZinnanti Surgical Instruments, Inc.1988-09-29
K820672HASSON BUEC-3Bivona Medical Technologies1982-07-30

Legacy Summary#

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FDA Review#

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