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510(k) K820672

Device
HASSON BUEC-3
Applicant
BIVONA MEDICAL TECHNOLOGIES
510(k) number
K820672
Product code
HDP  
Decision
Substantially Equivalent (SESE)
Decision date
1982-07-30
Date received
1982-03-11
Regulation
884.4530
Classification name
Elevator, Uterine
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K974801SINGLE CHANNEL BALLOON CANNULAConkin Surgical Instruments , Ltd.1998-07-09
K974563COLPO CUP CVC-2000Clinical Innovations, Inc.1998-03-02
K882054HYSTERO KITZinnanti Surgical Instruments, Inc.1988-09-29

Legacy Summary#

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FDA Review#

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