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510(k) K955443

Device
INTRAN PLUS
Applicant
UTAH MEDICAL PRODUCTS, INC.
510(k) number
K955443
Product code
HFN  
Decision
Substantially Equivalent (SESE)
Decision date
1996-02-20
Date received
1995-11-28
Regulation
884.2700
Classification name
Transducer, Pressure, Intrauterine
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
KEVIN L CORNWELL
Address
7043 S. 300 W. Midvale UT US 84047 84047

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HFN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250897Koala Intrauterine Pressure Catheter (IPC-5000E)Clinical Innovations, LLC2025-05-22
K974389KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETERClinical Innovations, Inc.1998-02-19
K973746PRE-FILLED SYRINGE FOR KOALA IUPClinical Innovations, Inc.1997-11-24
K961424INTRAN 500Utah Medical Products, Inc.1996-07-10
K954955STORC INTRAUTERINE PRESSURE CATHETERClinical Innovations, Inc.1996-04-17
K920375DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCERTelos Medical Corp.1992-10-27
K882224ULTRANS DISPOSABLE INTRAUTERINETelos Medical Corp.1989-10-12
K893503SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANSLaurel Medical Corp.1989-06-12

Legacy Summary#

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FDA Review#

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