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510(k) K882054

Device
HYSTERO KIT
Applicant
ZINNANTI SURGICAL INSTRUMENTS, INC.
510(k) number
K882054
Product code
HDP  
Decision
Substantially Equivalent (SESE)
Decision date
1988-09-29
Date received
1988-05-16
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#

Contact
THOMAS J ZINNANTI
Address
21540-B Prairie St. Chatsworth CA US 91311 91311

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
K820672HASSON BUEC-3Bivona Medical Technologies1982-07-30

Legacy Summary#

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FDA Review#

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