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510(k) K974028

Device
STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING
Applicant
CONCEPTUS, INC.
510(k) number
K974028
Product code
MKO  
Decision
Substantially Equivalent (SESE)
Decision date
1998-01-21
Date received
1997-10-23
Regulation
884.1690
Classification name
Falloposcope
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CONNIE ACUFF
Address
1021 Howard Ave. San Carlos CA US 94070 94070

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MKO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221965FemDx FalloViewFemdx Medsystems, Inc.2023-03-17
K962587CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEMConceptus, Inc.1997-01-31
K963580IMAGYN FALLOPOSCOPY SYSTEMImagyn Medical, Inc.1997-01-31

Legacy Summary#

summary

FDA Review#

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